Tasep

Tasep may be available in the countries listed below.

Ingredient matches for Tasep

Cefazolin

Cefazolin sodium salt (a derivative of Cefazolin) is reported as an ingredient of Tasep in the following countries:

• Spain

International Drug Name Search

Acido Alendronico Semanal Mabo

Acido Alendronico Semanal Mabo may be available in the countries listed below.

Ingredient matches for Acido Alendronico Semanal Mabo

Alendronic Acid

Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Acido Alendronico Semanal Mabo in the following countries:

• Spain

International Drug Name Search

Metamfetamine

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

N06BA03

CAS registry number (Chemical Abstracts Service)

0000537-46-2

Chemical Formula

C10-H15-N

Molecular Weight

149

Therapeutic Categories

Central stimulant

Sympathomimetic agent

Antihypotensive agent

Chemical Names

(S)-N-Methyl-1-phenylpropan-2-amin (IUPAC)

(+)-N-α-Deimethylphenethylamine (WHO)

Benzeneethanamine, N,α-dimethyl-, (S)-

Foreign Names

• Metamfetaminum (Latin)
• Metamfetamin (German)
• Métamphétamine (French)
• Metanfetamina (Spanish)

Generic Names

• Metamfetamina (OS: DCIT)
• Méthamphétamine (OS: DCF)
• BP 81 (IS)
• Desoxyephedrine (IS)
• F 914 (IS)
• Methylamphetamine (IS)
• Methamphetamine Hydrochloride (OS: JAN)
• DOE (IS)
• Phenylmethylaminopropanhydrochlorid (IS)
• Methamphetamine Hydrochloride (PH: USP 32, JP XIV)
• Methamphetamini hydrochloridum (PH: Ph. Int. 2)
• Methylamphetamine Hydrochloride (PH: BP 1973)

Brand Names

• Desoxyn
  Lundbeck, United States



• Cidrin
  Abbott, Chile



• Desoxyn
  Lundbeck, United States



• Philopon
  Dainippon Sumitomo, Japan

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IUPAC	International Union of Pure and Applied Chemistry
IS	Inofficial Synonym
JAN	Japanese Accepted Name
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Azatioprina Filaxis

Azatioprina Filaxis may be available in the countries listed below.

Ingredient matches for Azatioprina Filaxis

Azathioprine

Azathioprine is reported as an ingredient of Azatioprina Filaxis in the following countries:

• Argentina

International Drug Name Search

Erivedge

Dosage Form: capsule
FULL PRESCRIBING INFORMATION

WARNING: EMBRYO-FETAL DEATH AND SEVERE BIRTH DEFECTS

Erivedge (vismodegib) capsule can result in embryo-fetal death or severe birth defects. Erivedge is embryotoxic and teratogenic in animals. Teratogenic effects included severe midline defects, missing digits, and other irreversible malformations.

Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of these risks. Advise female patients of the need for contraception and advise male patients of the potential risk of Erivedge exposure through semen [see Warnings and Precautions (5.1), Use in Specific Populations (8.1, 8.6)].

Indications and Usage for Erivedge

Erivedge capsule is indicated for the treatment of adults with metastatic basal cell carcinoma, or with locally advanced basal cell carcinoma that has recurred following surgery or who are not candidates for surgery, and who are not candidates for radiation.

Erivedge Dosage and Administration

The recommended dose of Erivedge is 150 mg taken orally once daily until disease progression or until unacceptable toxicity [see Clinical Studies (14)].

Erivedge may be taken with or without food. Swallow capsules whole. Do not open or crush capsules.

If a dose of Erivedge is missed, do not make up that dose; resume dosing with the next scheduled dose.

Dosage Forms and Strengths

Erivedge (vismodegib) capsules, 150 mg. The capsule has a pink opaque body and a grey opaque cap, with “150 mg” printed on the capsule body and “VISMO” printed on the capsule cap in black ink.

Contraindications

None.

Warnings and Precautions

Embryo-Fetal Death and Severe Birth Defects

Erivedge capsules can cause fetal harm when administered to a pregnant woman based on its mechanism of action. Vismodegib is teratogenic, embryotoxic, and fetotoxic in rats at maternal exposures lower than the human exposures at the recommended dose of 150 mg/day. In rats, malformations included craniofacial anomalies, open perineum, and absent or fused digits. Fetal retardations and variations were also observed.

Verify pregnancy status prior to the initiation of Erivedge. Advise male and female patients of the risks of embryo-fetal death and severe birth defects and the need for contraception during and after treatment. Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant. Female and male patients of reproductive potential should be counseled regarding pregnancy prevention and planning. If Erivedge is used during pregnancy or if a patient becomes pregnant while taking (or for a male patient, if his female partner is exposed to) Erivedge, the patient should be apprised of the potential hazard to the fetus. Report immediately exposure to Erivedge during pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage women who may have been exposed to Erivedge during pregnancy, either directly or through seminal fluid, to participate in the Erivedge pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at 1-888-835-2555 [see Boxed Warning, Use in Specific Populations (8.1, 8.6)].

Blood Donation

Advise patients not to donate blood or blood products while receiving Erivedge and for at least 7 months after the last dose of Erivedge.

Adverse Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Erivedge capsule was administered as monotherapy at doses ≥ 150 mg orally daily in four open-label, uncontrolled, dose-ranging or fixed single dose clinical trials enrolling a total of 138 patients with advanced basal cell carcinoma (BCC). The median age of these patients was 61 years (range 21 to 101), 100% were White (including Hispanics), and 64% were male. The median duration of treatment was approximately 10 months (305 days; range 0.7 to 36 months); 111 patients received Erivedge for 6 months or longer.

The most common adverse reactions (≥ 10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia (Table 1).

Table 1: Adverse Reactions Occurring in ≥10% of Advanced BCC Patients

* MedDRA = Medical Dictionary for Regulatory Activities. † aBCC = Advanced Basal Cell Carcinoma. ‡ Grading according to NCI-CTCAE v3.0.
MedDRA Preferred Term*	All aBCC† Patients (N = 138)
	All Grades‡ (%)	Grade 3 (%)	Grade 4 (%)
Gastrointestinal disorders
Nausea	42 (30.4%)	1 (0.7%)	-
Diarrhea	40 (29.0%)	1 (0.7%)	-
Constipation	29 (21.0%)	-	-
Vomiting	19 (13.8%)	-	-
General disorders and administration site conditions
Fatigue	55 (39.9%)	7 (5.1%)	1 (0.7%)
Investigations
Weight loss	62 (44.9%)	10 (7.2%)	-
Metabolism and nutrition disorders
Decreased appetite	35 (25.4%)	3 (2.2%)	-
Musculoskeletal and connective tissue disorders
Muscle spasms	99 (71.7%)	5 (3.6%)	-
Arthralgias	22 (15.9%)	1 (0.7%)
Nervous system disorders
Dysgeusia	76 (55.1%)	-	-
Ageusia	15 (10.9%)	-	-
Skin and subcutaneous tissue disorders
Alopecia	88 (63.8%)	-	-

Amenorrhea:

In clinical trials, a total of 3 of 10 pre-menopausal women developed amenorrhea while receiving Erivedge [see Non-Clinical Toxicology (13.1)].

Laboratory Abnormalities:

Treatment-emergent Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%).

Drug Interactions

Effects of Other Drugs on Vismodegib

Drugs that Inhibit or Induce Drug Metabolizing Enzymes

Vismodegib elimination involves multiple pathways. Vismodegib is predominantly excreted as an unchanged drug. Several minor metabolites are produced by multiple CYP enzymes. Although vismodegib is a substrate of CYP2C9 and CYP3A4 in vitro, CYP inhibition is not predicted to alter vismodegib systemic exposure since similar steady-state plasma vismodegib concentrations were observed in patients in clinical trials concomitantly treated with CYP3A4 inducers (i.e., carbamazepine, modafinil, phenobarbital) and those concomitantly treated with CYP3A4 inhibitors (i.e., erythromycin, fluconazole).

Drugs that Inhibit Drug Transport Systems

In vitro studies indicate that vismodegib is a substrate of the efflux transporter P-glycoprotein (P-gp). When Erivedge is coadministered with drugs that inhibit P-gp (e.g. clarithromycin, erythromycin, azithromycin), systemic exposure of vismodegib and incidence of adverse events of Erivedge may be increased.

Drugs that Affect Gastric pH

Drugs that alter the pH of the upper GI tract (e.g. proton pump inhibitors, H2-receptor antagonists, and antacids) may alter the solubility of vismodegib and reduce its bioavailability. However, no formal clinical study has been conducted to evaluate the effect of gastric pH altering agents on the systemic exposure of vismodegib. Increasing the dose of Erivedge when coadministered with such agents is not likely to compensate for the loss of exposure. When Erivedge is coadministered with a proton pump inhibitor, H2-receptor antagonist or antacid, systemic exposure of vismodegib may be decreased and the effect on efficacy of Erivedge is unknown.

Effects of Vismodegib on Other Drugs

Results of a drug-drug interaction study conducted in cancer patients demonstrated that the systemic exposure of rosiglitazone (a CYP2C8 substrate) or oral contraceptives (ethinyl estradiol and norethindrone) is not altered when either drug is co-administered with vismodegib.

In vitro studies indicate that vismodegib is an inhibitor of CYP2C8, CYP2C9, CYP2C19 and the transporter BCRP. Vismodegib does not induce CYP1A2, CYP2B6, or CYP3A4/5 in human hepatocytes.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category D

Erivedge capsule can cause fetal harm when administered to a pregnant female based on its mechanism of action. Vismodegib is teratogenic in rats at doses corresponding to an exposure of 20% of the exposure at the recommended human dose (estimated AUC0-24hr steady-state exposure). In rats, malformations included craniofacial anomalies, open perineum, and absent or fused digits. Fetal retardations and variations were also observed. Vismodegib is embryolethal in rats at exposures within the range achieved at the recommended human dose. If Erivedge is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the embryo or fetus. Report immediately exposure to Erivedge during pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage women who may have been exposed to Erivedge during pregnancy, either directly or through seminal fluid, to participate in the Erivedge pregnancy pharmacovigilance program by contacting the Genentech Adverse Event Line at 1-888-835-2555 [see Boxed Warning, Warnings and Precautions (5.1)].

In an embryo-fetal developmental toxicity study, pregnant rats were administered oral vismodegib at doses of 10, 60, or 300 mg/kg/day during the period of organogenesis. Pre- and post-implantation loss were increased at doses of ≥ 60 mg/kg/day (approximately ≥ 2 times the systemic exposure (AUC) in patients at the recommended human dose), which included early resorption of 100% of the fetuses. A dose of 10 mg/kg/day (approximately 0.2 times the AUC in patients at the recommended dose) resulted in malformations (including missing and/or fused digits, open perineum and craniofacial anomalies) and retardations or variations (including dilated renal pelvis, dilated ureter, and incompletely or unossified sternal elements, centra of vertebrae, or proximal phalanges and claws).

Nursing Mothers

It is not known whether vismodegib is excreted in human breast milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from Erivedge, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

The safety and effectiveness of Erivedge capsule have not been established in pediatric patients.

In repeat-dose toxicology studies in rats, administration of oral vismodegib resulted in toxicities in bone and teeth. Effects on bone consisted of closure of the epiphyseal growth plate when oral vismodegib was administered for 26 weeks at ≥ 50 mg/kg/day (approximately ≥ 0.4 times the systemic exposure (AUC) in patients at the recommended human dose). Abnormalities in growing incisor teeth (including degeneration/necrosis of odontoblasts, formation of fluid-filled cysts in the dental pulp, ossification of the root canal, and hemorrhage resulting in breakage or loss of teeth) were observed after administration of oral vismodegib at ≥ 15 mg/kg/day (approximately ≥ 0.2 times the AUC in patients at the recommended human dose).

Geriatric Use

Clinical studies of Erivedge capsule did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

Females of Reproductive Potential and Males

Erivedge capsule can cause harm to the embryo or fetus when administered during pregnancy. Counsel female and male patients regarding pregnancy prevention and planning. Advise patients to contact their healthcare provider immediately if they suspect they (or, for males, their female partner) may be pregnant [see Boxed Warning, Warnings and Precautions (5.1), Use in Specific Populations (8.1)].

Female patients

Determine pregnancy status within 7 days prior to initiation of treatment in females of reproductive potential. For females with a negative pregnancy test, initiate a highly effective form of contraception (failure rate of less than 1%) prior to the first dose. Continue highly effective contraception during therapy and for 7 months after the last dose of Erivedge. If a patient becomes pregnant while taking Erivedge, or during the 7 months after the last dose of treatment, report the pregnancy to the Genentech Adverse Event Line at 1-888-835-2555. Encourage pregnant females to participate in the Erivedge pregnancy pharmacovigilance program by calling the Genentech Adverse Event Line at 1-888-835-2555. Counsel pregnant females about the teratogenic risk to the fetus.

Amenorrhea has been observed in clinical trials in females of reproductive potential. Reversibility of amenorrhea is unknown [see Adverse Reactions (6), Nonclinical Toxicology (13.1)].

Male patients

Male patients should use condoms with spermicide, even after a vasectomy, during sexual intercourse with female partners while being treated with Erivedge capsule and for 2 months after the last dose to avoid exposing an embryo or fetus to vismodegib.

Hepatic Impairment

The safety and effectiveness of Erivedge capsule have not been established in patients with hepatic impairment [see Clinical Pharmacology (12.3)].

Renal Impairment

The safety and effectiveness of Erivedge capsule have not been established in patients with renal impairment [see Clinical Pharmacology (12.3)].

Overdosage

There is no information on overdosage in humans. In clinical trials, Erivedge capsule was administered at 540 mg orally once daily; exposure did not increase between 150 mg and 540 mg daily.

Erivedge Description

Vismodegib is an inhibitor of the hedgehog (Hh) signaling pathway, which is described chemically as 2‑Chloro‑N‑(4‑chloro‑3‑(pyridin‑2‑yl)phenyl)‑4‑(methylsulfonyl)benzamide. The molecular formula is C19H14Cl2N2O3S. The molecular weight is 421.30 g/mol and the structural formula is:

Vismodegib is a crystalline free base with a pKa (pyridinium cation) of 3.8, appearing as a white to tan powder. The solubility of vismodegib is pH dependent with 0.1 μg/mL at pH 7 and 0.99 mg/mL at pH 1. The partition coefficient (log P) is 2.7.

Each Erivedge (vismodegib) capsule for oral administration contains 150 mg vismodegib and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, povidone, sodium starch glycolate, talc, and magnesium stearate (non-bovine). The capsule shell contains gelatin, titanium dioxide, red iron oxide, and black iron oxide. The black printing ink contains shellac and black iron oxide.

Erivedge - Clinical Pharmacology

Mechanism of Action

Vismodegib is an inhibitor of the Hedgehog pathway. Vismodegib binds to and inhibits Smoothened, a transmembrane protein involved in Hedgehog signal transduction.

Pharmacokinetics

Absorption

Vismodegib is a highly permeable compound with low aqueous solubility (BCS Class 2). The single dose absolute bioavailability of vismodegib is 31.8%. Absorption is saturable as evidenced by the lack of dose proportional increase in exposure after a single dose of 270 mg or 540 mg vismodegib. Erivedge capsule may be taken without regard to meals because the systemic exposure of vismodegib at steady state is not affected by food.

Distribution

The volume of distribution of vismodegib ranges from 16.4 to 26.6 L. Vismodegib plasma protein binding in patients is greater than 99%. Vismodegib binds to both human serum albumin and alpha-1-acid glycoprotein (AAG) and binding to AAG is saturable.

Metabolism

Greater than 98% of the total circulating drug-related components are the parent drug. Metabolic pathways of vismodegib in humans include oxidation, glucuronidation, and pyridine ring cleavage. The two most abundant oxidative metabolites recovered in feces are produced in vitro by recombinant CYP2C9 and CYP3A4/5.

Elimination

Vismodegib and its metabolites are eliminated primarily by the hepatic route with 82% of the administered dose recovered in the feces and 4.4% recovered in urine. The estimated elimination half-life (t1/2) of vismodegib is 4 days after continuous once-daily dosing and 12 days after a single dose.

Pharmacokinetics in Specific Populations

Hepatic Impairment: The effect of hepatic impairment on the systemic exposure of vismodegib has not been studied.

Renal Impairment: The effect of renal impairment on the systemic exposure of vismodegib has not been studied.

Population pharmacokinetic analyses showed that weight (range: 41-140 kg), age (range: 26-89 years), creatinine clearance (range: 30 to 80 mL/min), and sex do not have a clinically meaningful influence on the systemic exposure of vismodegib.

Cardiac Electrophysiology

In a thorough QTc study in 60 healthy subjects, there was no effect of therapeutic doses of Erivedge on the QTc interval.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies with vismodegib have not been conducted. Pilomatricoma (a benign cutaneous neoplasm) was observed in rats administered oral vismodegib for 26 weeks at 100 mg/kg/day (approximately 0.8 times the systemic exposure (AUC) in patients at the recommended human dose).

Vismodegib was not mutagenic in the in vitro bacterial reverse mutation (Ames) assay and was not clastogenic in the in vitro human chromosomal aberration assay in human peripheral blood lymphocytes or in the in vivo rat bone marrow micronucleus assay.

Studies to assess the potential of vismodegib to affect fertility have not been conducted; however, data from repeat-dose toxicology studies in rats and dogs indicate that male and female reproductive function and fertility may be impaired in patients receiving Erivedge capsule. In a 26-week toxicology study in rats, a relative decrease in percent motile sperm was observed at ≥ 15 mg/kg/day (approximately ≥ 0.3 times the AUC in patients at the recommended human dose). In dogs, increased numbers of degenerating germ cells and hypospermia were observed in young animals administered oral vismodegib for 4 weeks at ≥ 50 mg/kg/day (approximately ≥ 2 times the AUC in patients at the recommended human dose). No corresponding findings were observed in sexually mature dogs at similar doses in 13-week and 26-week toxicology studies. A decrease in the number of corpora lutea was observed in female rats administered oral vismodegib for 26 weeks at 100 mg/kg/day (approximately 0.8 times the AUC in patients at the recommended human dose).

Animal Toxicology

Neurologic effects characterized as limb or body tremors or twitching were observed in rats administered oral vismodegib for 4 weeks or longer at ≥ 50 mg/kg/day (approximately ≥ 0.4 times the AUC in patients at the recommended human dose). These observations resolved upon discontinuation of dosing and were not associated with microscopic findings.

Clinical Studies

A single, international, single-arm, multi-center, open-label, 2-cohort trial was conducted in 104 patients with either metastatic basal cell carcinoma (mBCC) (n = 33) or locally advanced BCC (laBCC) (n = 71). Patients with laBCC were required to have lesions that had recurred after radiotherapy, unless radiotherapy was contraindicated or inappropriate (e.g. Gorlin syndrome; limitations because of location of tumor or cumulative prior radiotherapy dose), and where the lesions were either unresectable or surgical resection would result in substantial deformity. Patients were to receive 150 mg vismodegib per day orally until disease progression or unacceptable toxicity.

The major efficacy outcome measure of the trial was objective response rate (ORR) as assessed by an independent review facility (IRF). In the mBCC cohort, tumor response was assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. In the laBCC cohort, tumor response evaluation included measurement of externally assessable tumor (including scar) and assessment for ulceration in photographs, radiographic assessment of target lesions (if appropriate), and tumor biopsy. An objective response in laBCC required at least one of the following criteria and absence of any criterion for disease progression: (1) ≥ 30% reduction in lesion size [sum of the longest diameter (SLD)] from baseline in target lesions by radiographic assessment; (2) ≥ 30% reduction in SLD from baseline in externally visible dimension of target lesions; (3) complete resolution of ulceration in all target lesions. Complete response was defined as objective response (as defined above) with no residual BCC on sampling tumor biopsy. Disease progression was defined as any of the following: (1) ≥ 20% increase in the SLD from nadir in target lesions (either by radiography or by externally visible dimension); (2) new ulceration of target lesions persisting without evidence of healing for at least 2 weeks; (3) new lesions by radiographic assessment or physical examination; (4) progression of non-target lesions by RECIST.

Of the 104 patients enrolled, 96 patients were evaluable for ORR. Twenty-one percent of patients carried a diagnosis of Gorlin syndrome. The median age of the efficacy evaluable population was 62 years (46% were at least 65 years old), 61% male and 100% White. For the mBCC cohort (n = 33), 97% of patients had prior therapy including surgery (97%), radiotherapy (58%), and systemic therapies (30%). For the laBCC cohort (n = 63), 94% of patients had prior therapies including surgery (89%), radiotherapy (27%), and systemic/topical therapies (11%). The median duration of treatment was 10.2 months (range 0.7 to 18.7 months).

The key outcome measures are presented in Table 2, below.

Table 2: Objective Response Rate: Efficacy-Evaluable Patients*

* Patients who received at least one dose of Erivedge with independent pathologist-confirmed diagnosis of BCC † IRF = Independent Review Facility ‡ For laBCC, complete response was defined as objective response with no residual BCC on sampling tumor biopsy. § CI = Confidence Interval ¶ NE = Not estimable
	mBCC (n = 33)	laBCC (n = 63)
IRF†-Confirmed ORR, n (%)     (95%CI)	10 (30.3) (15.6, 48.2)	27 (42.9) (30.5, 56.0)
Complete response‡	0 (0.0)	13 (20.6)
Partial response	10 (30.3)	14 (22.2)
Median Response Duration (months)	7.6	7.6
(95% CI§)	(5.6, NE¶)	(5.7, 9.7)

How Supplied/Storage and Handling

Each Erivedge (vismodegib) capsule has a pink opaque body and a grey opaque cap with “150 mg” printed on the capsule body and “VISMO” printed on the capsule cap in black ink. Erivedge capsules are available in bottles of 28 capsules (NDC 50242-140-01).

Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Patient Counseling Information

See FDA-approved patient labeling (Medication Guide).

• Advise patients that Erivedge exposure during pregnancy can cause embryo-fetal death or severe birth defects.


• Instruct female patients of reproductive potential to use a highly effective form of contraception (failure rate of less than 1%) while taking Erivedge and for at least 7 months after the last dose of Erivedge.


• Instruct all male patients, even those with prior vasectomy, to use condoms with spermicide, during sexual intercourse with female partners while taking Erivedge and for at least 2 months after the last dose of Erivedge.


• Instruct patients to immediately contact their healthcare provider if they (or, for males, their female partner) become pregnant or if pregnancy is suspected following exposure to Erivedge.


• Instruct patients to immediately report any pregnancy exposure to Erivedge and encourage participation in the Erivedge pregnancy pharmacovigilance program by calling the Genentech Adverse Event Line at 1-888-835-2555.


• Inform female patients of the potential for serious adverse reactions in nursing infants from Erivedge, taking into account the importance of the drug to the mother.


• Advise patients not to donate blood or blood products while taking Erivedge and for at least 7 months after the last dose of Erivedge.


• Advise patients to swallow Erivedge capsules whole and not to crush or open the capsules.

Erivedge™ [vismodegib] capsule
Manufactured by: Patheon, Inc. Mississauga, Canada Distributed by: Genentech USA, Inc. A Member of the Roche Group 1 DNA Way South San Francisco, CA 94080-4990	Erivedge is a registered trademark of Genentech, Inc. ©2012 Genentech, Inc. 10135493

MEDICATION GUIDE

Erivedge™ (EH-rih-vej)

(vismodegib)

capsule

Read this Medication Guide before you start taking Erivedge and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about Erivedge?

Erivedge can cause your baby to die before it is born (be stillborn) or cause your baby to have severe birth defects.

For females who can become pregnant:

• You should talk with your healthcare provider about the risks of Erivedge to your unborn child.


• Your healthcare provider should do a pregnancy test within 7 days before you start taking Erivedge to find out if you are pregnant.


• In order to avoid pregnancy, you should start using highly effective birth control before you start Erivedge, and continue to use highly effective birth control during treatment, and for 7 months after your last dose of Erivedge. Talk with your healthcare provider about what birth control method is right for you during this time.


• Talk to your healthcare provider right away if you have unprotected sex or if you think that your birth control has failed.


• Tell your healthcare provider right away if you become pregnant or think that you may be pregnant.

For males:

• You should always use a condom with a spermicide, even if you have had a vasectomy, during sex with female partners while you are taking Erivedge and for 2 months after your last dose to protect your female partner from being exposed to Erivedge.


• Tell your healthcare provider right away if your partner becomes pregnant or thinks she is pregnant while you are taking Erivedge.

Exposure to Erivedge during pregnancy:

If you think that you or your female partner may have been exposed to Erivedge during pregnancy, talk to your healthcare provider right away. Pregnant women are encouraged to participate in a program that collects information about exposure to Erivedge during pregnancy, and the effects on the mother and her unborn child. This program is called the Erivedge pregnancy pharmacovigilance program. You may participate in this program by calling the Genentech Adverse Event Line at 1-888-835-2555.

What is Erivedge?

Erivedge is a prescription medicine used to treat adults with a type of skin cancer, called basal cell carcinoma, that has spread to other parts of the body or that has come back after surgery or that your healthcare provider decides cannot be treated with surgery or radiation.

It is not known if Erivedge is safe and effective in children.

What should I tell my healthcare provider before taking Erivedge?

Before taking Erivedge, tell your healthcare provider if you:

• are pregnant or plan to become pregnant. See “What is the most important information I should know about Erivedge?”


• are breastfeeding or plan to breastfeed. It is not known if Erivedge passes into your breast milk. You and your healthcare provider should decide if you will take Erivedge or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Erivedge?

• Take Erivedge exactly as your healthcare provider tells you.


• You can take Erivedge with or without food.


• Swallow Erivedge capsules whole. Do not open or crush the capsules.


• Take Erivedge one time each day.


• If you miss a dose, skip the missed dose. Just take your next scheduled dose.

What should I avoid while taking Erivedge?

• Do not donate blood or blood products while you are taking Erivedge and for 7 months after your last dose.

What are the possible side effects of Erivedge?

Erivedge can cause serious side effects, including:

• See “What is the most important information I should know about Erivedge?”

The most common side effects of Erivedge are:

• muscle spasms


• hair loss


• change in how things taste or loss of taste


• weight loss


• tiredness


• nausea


• diarrhea


• decreased appetite


• constipation


• vomiting


• joint aches

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Erivedge. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Genentech, Inc. at 1-888-835-2555.

How should I store Erivedge?

• Store Erivedge at room temperature between 68°F to 77°F (20°C to 25°C).

Keep Erivedge and all medicines out of the reach of children.

General information about Erivedge

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Erivedge for a condition for which it was not prescribed. Do not give Erivedge to other people, even if they have the same symptoms that you have. It may harm them.

This Medication Guide summarizes the most important information about Erivedge. If you would like more information, ask your health care provider. You can ask your healthcare provider or pharmacist for the FDA-approved information about Erivedge that is written for healthcare professionals.

For more information, call 1-855-737-4833 or visit www.Erivedge.com

What are the ingredients in Erivedge?

Active ingredient: vismodegib

Inactive ingredients: microcrystalline cellulose, lactose monohydrate, sodium lauryl sulfate, povidone, sodium starch glycolate, talc, magnesium stearate (non bovine). The capsule shell contains gelatin, titanium dioxide, red iron oxide, and black iron oxide. The black printing ink contains shellac and black iron oxide.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

MG Issued: 01/2012

Manufactured by:

Patheon, Inc.

Mississauga, Canada

Distributed by:

Genentech USA, Inc.

A Member of the Roche Group

1 DNA Way

South San Francisco, CA 940804990

Erivedge is a registered trademark of Genentech, Inc.

©2012 Genentech, Inc.

10135493

PRINCIPAL DISPLAY PANEL - Erivedge Capsules 150 mg Folding Carton

NDC 50242-140-01

Erivedge™

(vismodegib) capsules

150 mg

Each capsule contains 150 mg of vismodegib

Rx only

Attention Pharmacist: Dispense the accompanying Medication Guide to each patient.

28 capsules

Genentech

10135488

Erivedge Principal Display Panel

Erivedge  vismodegib  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 50242-140 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength vismodegib (vismodegib) vismodegib 150 mg

Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline   lactose monohydrate   sodium lauryl sulfate   povidone K29/32   sodium starch glycolate type a potato   talc   magnesium stearate   water   gelatin   titanium dioxide   ferric oxide red   ferrosoferric oxide   shellac

Product Characteristics Color GRAY (gray opaque) , PINK (pink opaque) Score no score Shape CAPSULE (hard capsule) Size 19mm Flavor Imprint Code VISMO;150;mg Contains

Packaging # NDC Package Description Multilevel Packaging 1 50242-140-01 1 BOTTLE In 1 CARTON contains a BOTTLE, PLASTIC 1 28 CAPSULE In 1 BOTTLE, PLASTIC This package is contained within the CARTON (50242-140-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA203388	01/30/2012

Labeler - Genentech, Inc. (080129000)

Establishment
Name	Address	ID/FEI	Operations
Patheon Inc.		240769596	MANUFACTURE, PACK, LABEL

Establishment
Name	Address	ID/FEI	Operations
Patheon Inc.		259484350	ANALYSIS

Establishment
Name	Address	ID/FEI	Operations
Siegfried Ltd		480004571	API MANUFACTURE

Revised: 01/2012Genentech, Inc.

Valraizer

Valraizer may be available in the countries listed below.

Ingredient matches for Valraizer

Pranoprofen

Pranoprofen is reported as an ingredient of Valraizer in the following countries:

• Japan

International Drug Name Search

Vitamine C Aguettant

Vitamine C Aguettant may be available in the countries listed below.

Ingredient matches for Vitamine C Aguettant

Ascorbic Acid

Ascorbic Acid is reported as an ingredient of Vitamine C Aguettant in the following countries:

• France

International Drug Name Search

Valacyclovir Hydrochloride

Valacyclovir Hydrochloride may be available in the countries listed below.

Ingredient matches for Valacyclovir Hydrochloride

Valacyclovir

Valacyclovir Hydrochloride (USAN) is known as Valacyclovir in the US.

International Drug Name Search

Glossary

USAN	United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Hytone Cream

Pronunciation: hye-droe-KOR-ti-sone
Generic Name: Hydrocortisone
Brand Name: Examples include Cortizone-10 and Hytone

Hytone Cream is used for:

Reducing itching, redness, and swelling associated with many skin conditions.

Hytone Cream is a topical corticosteroid. It works by depressing the formation, release, and activity of different cells and chemicals that cause swelling, redness, and itching.

Do NOT use Hytone Cream if:

• you are allergic to any ingredient in Hytone Cream

Contact your doctor or health care provider right away if any of these apply to you.

Before using Hytone Cream:

Some medical conditions may interact with Hytone Cream. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a skin infection, measles, thinning of the skin, tuberculosis (TB), chicken pox, shingles, a positive TB skin test, or have recently had a vaccination


• if you have anal itching or bleeding or genital itching

Some MEDICINES MAY INTERACT with Hytone Cream. Because little, if any, of Hytone Cream is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Hytone Cream may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Hytone Cream:

Use Hytone Cream as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Apply a small amount of medicine to the affected area. Gently rub it in until it is evenly distributed. Wash your hands after applying Hytone Cream, unless your hands are part of the treated area.


• Do not bandage or wrap the affected area unless directed otherwise by your doctor.


• If you miss a dose of Hytone Cream, apply it as soon as possible. If you do not remember until the next day, skip the missed dose and go back to your regular dosing schedule.

Ask your health care provider any questions you may have about how to use Hytone Cream.

Important safety information:

• Do not use Hytone Cream for other skin conditions at a later time.


• If you are using Hytone Cream for a rectal condition, do not put Hytone Cream in the rectum using your fingers or any mechanical device or applicator.


• If Hytone Cream was prescribed to treat the diaper area of a child, avoid using tight-fitting diapers or plastic pants.


• Check with your doctor before having vaccinations while you are using Hytone Cream.


• Hytone Cream is for external use only. If you get Hytone Cream in your eyes, immediately flush them with cool tap water.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Hytone Cream while you are pregnant. It is not known if Hytone Cream is found in breast milk. If you are or will be breast-feeding while you use Hytone Cream, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Hytone Cream:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; cracking, softening, or streaking of the skin; excessive sweating; inflammation of the hair follicles; mild skin irritation or dryness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); infection; itching, burning, pain, redness, or swelling of the skin not present before using Hytone Cream; skin thinning and discoloration.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Hytone side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Hytone Cream may be harmful if swallowed.

Proper storage of Hytone Cream:

Store Hytone Cream at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Hytone Cream out of the reach of children and away from pets.

General information:

• If you have any questions about Hytone Cream, please talk with your doctor, pharmacist, or other health care provider.


• Hytone Cream is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Hytone Cream. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Hytone resources

• Hytone Side Effects (in more detail)
• Hytone Use in Pregnancy & Breastfeeding
• Hytone Drug Interactions
• Hytone Support Group
• 0 Reviews for Hytone - Add your own review/rating

Compare Hytone with other medications

• Anal Itching
• Aphthous Stomatitis, Recurrent
• Atopic Dermatitis
• Dermatitis
• Eczema
• Gingivitis
• Proctitis
• Pruritus
• Psoriasis
• Seborrheic Dermatitis
• Skin Rash
• Ulcerative Colitis, Active

Myocholine-Glenwood

Myocholine-Glenwood may be available in the countries listed below.

Ingredient matches for Myocholine-Glenwood

Bethanechol

Bethanechol Chloride is reported as an ingredient of Myocholine-Glenwood in the following countries:

• Belgium


• Germany


• Luxembourg


• Switzerland

International Drug Name Search

Citalopram Actavis

Citalopram Actavis may be available in the countries listed below.

Ingredient matches for Citalopram Actavis

Citalopram

Citalopram is reported as an ingredient of Citalopram Actavis in the following countries:

• Lithuania

Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Citalopram Actavis in the following countries:

• Austria


• Czech Republic


• Estonia


• Italy


• Latvia


• Netherlands


• Slovakia


• Sweden


• Switzerland

International Drug Name Search

Vizerul

Vizerul may be available in the countries listed below.

Ingredient matches for Vizerul

Ranitidine

Ranitidine hydrochloride (a derivative of Ranitidine) is reported as an ingredient of Vizerul in the following countries:

• Argentina


• Venezuela

International Drug Name Search

Meprozine

Pronunciation: me-PER-i-deen/proe-METH-a-zeen
Generic Name: Meperidine/Promethazine
Brand Name: Meprozine

Meprozine is used for:

Treating moderate pain and causing drowsiness in patients who have just had surgery or delivered a baby, or who have pain associated with cancer. It may also be used for other conditions as determined by your doctor.

Meprozine is a combination narcotic analgesic and phenothiazine. The narcotic works by dulling the pain perception center in the brain. The phenothiazine causes drowsiness.

Do NOT use Meprozine if:

• you are allergic to any ingredient in Meprozine


• you have a certain type of intestinal inflammation (pseudomembranous colitis) or diarrhea due to poisoning, severe drowsiness, or you are in a coma


• you have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days


• you are taking astemizole, cisapride, ritonavir, sibutramine, sodium oxybate (GHB), or terfenadine

Contact your doctor or health care provider right away if any of these apply to you.

Before using Meprozine:

Some medical conditions may interact with Meprozine. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have a history of breathing problems (eg, asthma, chronic obstructive pulmonary disease [COPD], cor pulmonale); low levels of oxygen or high levels of carbon dioxide in the blood; sickle cell anemia; low blood pressure; prostate problems; urinary blockage; lung, liver, or kidney problems; heart problems (eg, irregular heartbeat); seizures; or stomach or intestine problems (eg, inflammatory bowel disease)


• if you have a history of head injury, brain tumor or other growths, increased pressure in the brain, adrenal tumor or other problems (eg, Addison disease, pheochromocytoma), curved spine, or an underactive thyroid


• if you have a history of nervous system problems, bone marrow problems, blood problems (eg, porphyria), glaucoma or risk factors for glaucoma, increased eye pressure, Parkinson disease, or Reye syndrome


• if you regularly consume alcohol or have a history of alcohol or substance abuse/dependence, delirium tremens, mental or mood changes caused by a medicine or other substance, or suicidal thoughts or attempts


• if you are dehydrated, have been severely weakened, or have had recent surgery

Some MEDICINES MAY INTERACT with Meprozine. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Agonist/antagonist analgesics (eg, butorphanol, pentazocine) or naltrexone because they may decrease Meprozine's effectiveness


• MAOIs (eg, phenelzine) because the risk of serious side effects, including coma, difficulty breathing, low blood pressure, seizures, and irregular heartbeat, may be increased


• Astemizole, cisapride, haloperidol, or terfenadine because the risk of side effects, such as low blood pressure, seizure, or irregular heartbeat, may be increased


• Acyclovir, cimetidine, HIV protease inhibitors (eg, ritonavir), phenothiazines (eg, chlorpromazine), phenytoin, or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Meprozine's side effects


• Sibutramine because the risk of side effects, including increased body temperature, mental or mood changes, muscle twitching, or severe drowsiness, may be increased


• Barbiturate anesthetics (eg, thiopental), barbiturates (eg, phenobarbital), narcotic analgesics (eg, morphine), neuromuscular blockers (eg, pancuronium), or sodium oxybate (GHB) because the risk of their side effects may be increased by Meprozine


• Epinephrine, levodopa, or pergolide because their effectiveness may be decreased by Meprozine

This may not be a complete list of all interactions that may occur. Ask your health care provider if Meprozine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Meprozine:

Use Meprozine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Meprozine by mouth with or without food.


• If Meprozine is no longer needed, dispose of it as soon as possible. Ask your doctor or pharmacist how to dispose of Meprozine properly.


• If you miss a dose of Meprozine and you are taking it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Meprozine.

Important safety information:

• Meprozine may cause drowsiness, dizziness, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Meprozine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.


• Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Meprozine; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.


• Meprozine may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Meprozine. Symptoms may include fever; stiff muscles; confusion; abnormal thinking; fast or irregular heartbeat; and sweating. Contact your doctor at once if you have any of these symptoms.


• Do not suddenly stop taking Meprozine without first checking with your doctor.


• Tell your doctor or dentist that you take Meprozine before you receive any medical or dental care, emergency care, or surgery.


• Use Meprozine with caution in the ELDERLY; they may be more sensitive to its effects.


• Meprozine should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Meprozine while you are pregnant. Meprozine should not be used during labor or prior to the labor period because it may cause harmful side effects to the baby. Meprozine is found in breast milk. Do not breast-feed while using Meprozine.

When used for long periods of time or at high doses, Meprozine may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Meprozine stops working well. Do not take more than prescribed.

Some people who use Meprozine for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking Meprozine suddenly, you may have WITHDRAWAL symptoms. These may include anxiety; appetite loss; backache; chills; diarrhea; enlarged pupils; fast heartbeat or breathing rate; increased tears; irritability; muscle or joint pain; nausea; restlessness; runny nose; severe or persistent dizziness; sleeplessness; stomach cramps; sweating; vomiting; weakness; yawning.

Possible side effects of Meprozine:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; dizziness; drowsiness; dry mouth; lightheadedness; loss of appetite; nausea; sweating; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; difficulty urinating; fainting; fast, slow, or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or a leg; rigid muscles; seizure; slowed or difficult breathing; severe or persistent dizziness or drowsiness; sudden severe headache, nausea, vomiting, or stomach pain; tremor; uncontrolled muscle movements; vision changes; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Meprozine side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include chest pain; cold and clammy skin; lightheadedness; limp muscles; loss of consciousness; low body temperature; seizures; severe dizziness; severe drowsiness; slowed heartbeat; slowed or difficult breathing; small pupils.

Proper storage of Meprozine:

Store Meprozine at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Meprozine out of the reach of children and away from pets.

General information:

• If you have any questions about Meprozine, please talk with your doctor, pharmacist, or other health care provider.


• Meprozine is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Meprozine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Meprozine resources

• Meprozine Side Effects (in more detail)
• Meprozine Use in Pregnancy & Breastfeeding
• Meprozine Drug Interactions
• Meprozine Support Group
• 7 Reviews for Meprozine - Add your own review/rating

• Meprozine Concise Consumer Information (Cerner Multum)

Compare Meprozine with other medications

• Pain

Nia-Chrom

Generic Name: chromium supplement (Oral route, Parenteral route)

Commonly used brand name(s)

In the U.S.

• Amino-CR


• Chromacaps


• Chromate


• Chromax


• M2 Chromium


• Nia-Chrom

Available Dosage Forms:

• Tablet


• Capsule


• Capsule, Liquid Filled

Uses For Nia-Chrom

Chromium supplements are used to prevent or treat chromium deficiency.

The body needs chromium for normal growth and health. For patients who are unable to get enough chromium in their regular diet or who have a need for more chromium, chromium supplements may be necessary. They are generally taken by mouth but some patients may have to receive them by injection. Chromium helps your body use sugar properly. It is also needed for the breakdown of proteins and fats.

Lack of chromium may lead to nerve problems and may decrease the body's ability to use sugar properly.

There is not enough evidence to show that taking chromium supplements improves the way your body uses sugar (glucose tolerance).

Injectable chromium is given by or under the supervision of a health care professional. Other forms are available without a prescription.

Importance of Diet

For good health, it is important that you eat a balanced and varied diet. Follow carefully any diet program your health care professional may recommend. For your specific dietary vitamin and/or mineral needs, ask your health care professional for a list of appropriate foods. If you think that you are not getting enough vitamins and/or minerals in your diet, you may choose to take a dietary supplement.

Chromium is found in various foods, including brewer's yeast, calf liver, American cheese, and wheat germ.

The daily amount of chromium needed is defined in several different ways.

• For U.S.—


• Recommended Dietary Allowances (RDAs) are the amount of vitamins and minerals needed to provide for adequate nutrition in most healthy persons. RDAs for a given nutrient may vary depending on a person's age, sex, and physical condition (e.g., pregnancy).


• Daily Values (DVs) are used on food and dietary supplement labels to indicate the percent of the recommended daily amount of each nutrient that a serving provides. DV replaces the previous designation of United States Recommended Daily Allowances (USRDAs).

• For Canada—


• Recommended Nutrient Intakes (RNIs) are used to determine the amounts of vitamins, minerals, and protein needed to provide adequate nutrition and lessen the risk of chronic disease.

Because a lack of chromium is rare, there is no RDA or RNI for it. Normal daily recommended intakes for chromium are generally defined as follows:

• Infants and children—
  
  • Birth to 3 years of age—10 to 80 micrograms (mcg) a day.
  
  
  • 4 to 6 years of age—30 to 120 mcg a day.
  
  
  • 7 to 10 years of age—50 to 200 mcg a day.
  
  


• Adolescents and adults—50 to 200 mcg a day.

Before Using Nia-Chrom

If you are taking a dietary supplement without a prescription, carefully read and follow any precautions on the label. For these supplements, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Problems in children have not been reported with intake of normal daily recommended amounts.

Geriatric

Problems in older adults have not been reported with intake of normal daily recommended amounts.

Pregnancy

It is especially important that you are receiving enough vitamins and minerals when you become pregnant and that you continue to receive the right amount of vitamins and minerals throughout your pregnancy. The healthy growth and development of the fetus depend on a steady supply of nutrients from the mother. However, taking large amounts of a dietary supplement during pregnancy may be harmful to the mother and/or fetus and should be avoided.

Breast Feeding

It is important that you receive the right amounts of vitamins and minerals so that your baby will also get the vitamins and minerals needed to grow properly. However, taking large amounts of a dietary supplement while breast-feeding may be harmful to the mother and/or baby and should be avoided.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of dietary supplements in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Type 2 diabetes mellitus—Taking chromium supplements when you have a chromium deficiency may cause a change in the amount of insulin you need.

Proper Use of chromium supplement

This section provides information on the proper use of a number of products that contain chromium supplement. It may not be specific to Nia-Chrom. Please read with care.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (capsules and tablets):
  
  • To prevent deficiency, the amount taken by mouth is based on normal daily recommended intakes:
    
    • Adults and teenagers—50 to 200 micrograms (mcg) per day.
    
    
    • Children 7 to 10 years age—50 to 200 mcg per day.
    
    
    • Children 4 to 6 years of age—30 to 120 mcg per day.
    
    
    • Children birth to 3 years of age—10 to 80 mcg per day.
    
    
  
  
  • To treat deficiency:
    
    • Adults, teenagers, and children—Treatment dose is determined by prescriber for each individual based on severity of deficiency.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If you miss taking chromium supplements for one or more days there is no cause for concern, since it takes some time for your body to become seriously low in chromium. However, if your health care professional has recommended that you take chromium, try to remember to take it as directed every day.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Nia-Chrom Side Effects

No side effects or overdoses have been reported for chromium. However, check with your health care professional if you notice any unusual effects while you are taking it.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Nia-Chrom resources

• Nia-Chrom Side Effects (in more detail)
• Nia-Chrom Use in Pregnancy & Breastfeeding
• Nia-Chrom Drug Interactions
• Nia-Chrom Support Group
• 4 Reviews for Nia-Chrom - Add your own review/rating

Compare Nia-Chrom with other medications

• Diabetes, Type 2
• Vitamin/Mineral Supplementation and Deficiency

Vermi-cao

Vermi-cao may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Vermi-cao

Mebendazole

Mebendazole is reported as an ingredient of Vermi-cao in the following countries:

• Portugal

International Drug Name Search

Valproate EG

Valproate EG may be available in the countries listed below.

Ingredient matches for Valproate EG

Valproic Acid

Valproic Acid sodium (a derivative of Valproic Acid) is reported as an ingredient of Valproate EG in the following countries:

• Belgium

International Drug Name Search

Verbital

Verbital may be available in the countries listed below.

Ingredient matches for Verbital

Bezafibrate

Bezafibrate is reported as an ingredient of Verbital in the following countries:

• Greece

International Drug Name Search

Vérapamil

Vérapamil may be available in the countries listed below.

Ingredient matches for Vérapamil

Verapamil

Vérapamil (DCF) is known as Verapamil in the US.

International Drug Name Search

Glossary

DCF	Dénomination Commune Française

Click for further information on drug naming conventions and International Nonproprietary Names.

DMG Stamina

DMG Stamina may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for DMG Stamina

Glycine

Glycine is reported as an ingredient of DMG Stamina in the following countries:

• New Zealand

International Drug Name Search

Natacyn

Generic Name: Natamycin
Class: Antifungals
ATC Class: S01AA10
VA Class: OP210
CAS Number: 7681-93-8

Introduction

Antifungal antibiotic; polyene macrolide produced by Streptomyces natalensis.^{a b}

Uses for Natacyn

Ophthalmic Fungal Infections

Treatment of blepharitis, conjunctivitis, and keratitis caused by susceptible organisms, including Fusarium solani keratitis.^{a b}

Efficacy not established for the treatment of deep fungal stromal keratitis or as a single agent for the treatment of fungal endophthalmitis.^{a b}

Should not replace appropriate surgical procedures (e.g., conjunctival flap, penetrating keratoplasty) when indicated.^a

May be used in combination with atropine preparations as indicated.^a

Not effective for the treatment of intraocular scarring or loss of vision resulting from severe fungal corneal infections.^a

Natacyn Dosage and Administration

General

• 
  

  Prior to therapy, culture and identify the causative organism from corneal scrapings.^{a b}

  
  


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  Whenever possible, conduct in vitro susceptibility tests to determine the responsible organism.^{a b}

  
  


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  If no improvement after 7–10 days, reevaluate the patient.^{a b} Consider that the infection may be caused by a microorganism not susceptible to natamycin and perform additional laboratory testing.^b

  
  

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic suspension.^{a b}

For topical ophthalmic use only.^b Do not inject.^b

Avoid contamination of dropper tip.^b

Shake suspension well prior to each use.^b

Dosage

Adults

Ophthalmic Fungal Infections

Fungal Keratitis

Ophthalmic

Initially, 1 drop into the conjunctival sac of the affected eye(s) every 1–2 hours.^{a b} After 3–4 days, may decrease frequency to 1 drop 6–8 times daily.^a In many patients, may gradually decrease the dosage every 4–7 days to ensure complete elimination of the organism.^a Continue therapy for 14–21 days or until there is no evidence of active fungal keratitis.^{a b}

Fungal Blepharitis

Ophthalmic

Manufacturer states 1 drop into the conjunctival sac of the affected eye(s) 4–6 times daily may be adequate.^{a b}

Fungal Conjunctivitis

Ophthalmic

Manufacturer states 1 drop into the conjunctival sac of the affected eye(s) 4–6 times daily may be adequate.^{a b}

Special Populations

No special populations dosage recommendations at this time.^b

Cautions for Natacyn

Contraindications

• 
  

  For ophthalmic fungal infections: Topical corticosteroids.^a

  
  


• 
  

  Known hypersensitivity to the drug or any ingredient in the formulation.^{a b}

  
  

Warnings/Precautions

Sensitivity Reactions

Allergic Reaction

Possible allergic reaction (conjunctival chemosis and hyperemia) reported.^{a b}

General Precautions

Patient Monitoring

Because of limited clinical experience, the manufacturer recommends monitoring patients for adverse drug reactions at least twice weekly.^{a b}

If signs of drug toxicity occur, discontinue the drug.^{a b}

Specific Populations

Pregnancy

Category C.^b

Lactation

Not known whether distributed into milk.^b Caution if used in nursing women.^b

Pediatric Use

Safety and efficacy not established.^b

Interactions for Natacyn

Specific Drugs

Drug	Interaction	Comments
Corticosteroids, topical ophthalmic	Risk of accelerating spread of infectiona	Concurrent use contraindicated in ophthalmic fungal infectionsa

Natacyn Pharmacokinetics

Absorption

Bioavailability

Following topical application to eye, effective concentrations obtained in corneal stroma but not in intraocular fluid.^b

Not systemically absorbed following topical application to eye.^{a b}

Not significantly absorbed from mucous membranes or intact or denuded skin.^a

Onset

Epithelial fungal infections may show response to treatment within 2 days and heal completely in 2–4 weeks.^a

Distribution

Extent

Following topical application to the eye, adheres to the cornea in areas of epithelial ulceration and is retained in the conjunctival fornices.^{a b}

Not known whether natamycin is distributed into milk.^b (See Bioavailability under Pharmacokinetics.)

Stability

Storage

Ophthalmic

Suspension

2–24°C; do not freeze.^{a b} Protect from light and excessive heat.^{a b}

Actions and SpectrumActions

• 
  

  Predominately fungicidal.^{a b}

  
  


• 
  

  Binds to sterols in the fungal cell membrane.^{a b} Affects permeability of the selective membrane barrier, depleting potassium and other essential cellular constituents.^{a b}

  
  


• 
  

  Mechanism of action appears similar to that of amphotericin B and nystatin.^a

  
  


• 
  

  Active in vitro against Aspergillus, Blastomyces dermatitidis, Candida, Cephalosporium, Coccidioides immitis, Cryptococcus neoformans, Curvularia, Epidermophyton, Fusarium, Histoplasma capsulatum, Microsporum, Penicillium, and Sporothrix schenckii.^{a b}

  
  


• 
  

  Has some activity in vitro and in vivo against Trichomonas vaginalis.^a

  
  


• 
  

  Inactive against gram-positive and gram-negative bacteria and viruses.^{a b}

  
  

Advice to Patients

• 
  

  Importance of not touching tip of container to the eye, eyelid, fingers, or any other surface to avoid contamination.^b

  
  


• 
  

  Importance of informing clinician if condition worsens or does not improve after 7–10 days of therapy or if any adverse reactions occur.^b

  
  


• 
  

  Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.^b

  
  


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  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^b

  
  


• 
  

  Importance of informing patients of other important precautionary information.^b (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Natamycin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Ophthalmic	Suspension	5%	Natacyn	Alcon

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2009. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

a. AHFS drug information 2008. McEvoy GK, ed. Natamycin. Bethesda, MD: American Society of Health-System Pharmacists; 2008: 2858.

b. Alcon. Natacyn (natamycin 5% ophthalmic suspension) prescribing information. Fort Worth, TX; 2000 Oct.

More Natacyn resources

• Natacyn Side Effects (in more detail)
• Natacyn Dosage
• Natacyn Use in Pregnancy & Breastfeeding
• Natacyn Support Group
• 0 Reviews for Natacyn - Add your own review/rating

• Natacyn Prescribing Information (FDA)


• Natacyn Concise Consumer Information (Cerner Multum)


• Natacyn Advanced Consumer (Micromedex) - Includes Dosage Information


• Natacyn MedFacts Consumer Leaflet (Wolters Kluwer)

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