This site is intended for healthcare professionals

ADD THIS DRUG TO MY LIST

Select the drug indication to add to your list

AMNESTEEM
Acne
Compare To Related Drugs
View/Edit/Compare Drugs In My List

Only 4 drugs may be compared at once

Drug Name:

AMNESTEEM Rx

Generic Name and Formulations:
Isotretinoin 10mg, 20mg, 40mg; caps; contains soy.

Company:
Mylan Inc.

Therapeutic Use:

Indications for AMNESTEEM:

Severe recalcitrant nodular acne unresponsive to conventional therapy (eg, systemic antibiotics).

Adult:

Take with meals. 0.5–1mg/kg per day in 2 divided doses; treat for 15–20 weeks or less if nodule count reduced by >70%; max 2mg/kg per day. Repeat course only if necessary after at least 2 months drug-free interval.

Children:

Not recommended.

Contraindications:

Pregnancy (Cat.X). Nursing mothers.

Warnings/Precautions:

Must register patient in iPLEDGE program (see full labeling for restrictions and stipulations on use). Be fully familiar with drug's toxicity before use. Counsel patient about need for contraception; obtain 2 negative pregnancy tests prior to initiation of drug and monthly thereafter; use 2 effective methods of contraception 1 month before, during, and 1 month after therapy; get written informed consent (see literature). Monitor blood lipids initially and for 1st 4 weeks. History of psychiatric disorders; monitor and discontinue if signs and symptoms develop. Osteoporosis risk (eg, osteomalacia, anorexia nervosa) or risk of metabolic bone disorders. Monitor bone growth, glucose, sed rate, CBC, liver enzymes. Discontinue if visual or auditory disturbances; colitis, pancreatitis or hepatitis symptoms; uncontrolled hypertriglyceridemia, or significant decrease in WBCs occurs. Refer to specialist if papilledema or hearing disturbances occur. Do not donate blood during and for 1 month after therapy. Avoid wax epilation or skin resurfacing during and for 6 months after therapy. Adolescents. Avoid sun, UV light. Reduced tolerance to contact lenses. Max 1/℞.

Interactions:

Avoid tetracyclines (increased risk of pseudotumor cerebri), Vit. A, or alcohol consumption. Avoid St. John's wort with hormonal contraceptives. Low-dose progestin-only contraceptives (ie, minipills) may provide inadequate contraception. Caution with drugs that can disturb bone metabolism (eg, anticonvulsants, systemic corticosteroids).

Pharmacological Class:

Retinoid.

Adverse Reactions:

Dry skin, eyes, nose, mouth, and lips, transient exacerbation of acne, dizziness, drowsiness, headache, abnormal menses, bronchospasm, voice changes, alopecia, epistaxis, flushing, hirsutism, rash, GI disturbances, photosensitivity, abnormal wound healing, depression, psychosis, suicidal ideation, aggression, pseudotumor cerebri, pancreatitis; visual, auditory, or lipid disturbances; hepatotoxicity, glomerulonephritis, inflammatory bowel disease, osteopenia, osteoporosis, hyperostosis, premature epiphyseal closure, reversible corneal opacities, decreased night vision, musculoskeletal symptoms, back/chest pain, blood dyscrasias, glucose intolerance, palpitation, thrombotic disease.

REMS:

YES

Generic Availability:

NO

How Supplied:

Caps 10mg, 20mg—3 x 10 ℞ packs; 40mg—3 x 10, 10 x 10 ℞ packs

Join MIMS Learning now to manage all your CPD and notes in one place!

By registering you agree with our Terms and Conditions and Privacy Policy.


Already a MIMS Learning member?

Sign In Now »
Red flag CPD modules
0.50 Credits
Red flags

Fever in adults - red flag symptomsExternal web site

Fever in adults can have potentially serious causes, ranging from sepsis to malignancy. Dr Pipin Singh...

0.50 Credits
Red flags

Bone pain - red flag symptomsExternal web site

In this article Dr Pipin Singh advises on how to identify red flags in patients presenting with bone...

0.50 Credits
Red flags

Pregnancy - red flag symptomsExternal web site

Dr Matthew West covers the red flags to look out for in pregnancy, including back pain, bleeding, headaches...

Font Awesome Icons
View more
Clinical review CPD modules
1.50 Credits
Clinical Review

Bronchiectasis: clinical reviewExternal web site

This article, updated in 2016 by Dr Anthony De Soyza, advises on causes, investigations and managing...

1.50 Credits
Clinical Review

Brugada syndrome: clinical reviewExternal web site

Dr Keith Barnard discusses the aetiology and symptoms of Brugada syndrome. Key learning points for GPs...

1.50 Credits
Clinical Review

Measles: clinical reviewExternal web site

Dr Kirsty Le Doare and Dr Nuria Martinez-Alier describe the signs and symptoms of measles and outline...

Font Awesome Icons
View more

is free, fast, and customized just for you!

Already a member?

Sign In Now »