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lsoace

For Doctors
For patients

Each soft gelatin capsule contains:
Isotretinoin : 20 mg
Grape Seed Extract : 25 mg

Isotretinoin is a retinoid, which inhibits sebaceous gland function and keratinization. Grape seed extract is a natural plant substance that has a concentrated source of oligomeric proanthocyanidins (OPC). These antioxidants help protect cells from free radical damage

HIGHLIGHTS (USPs) Isoace gives

Near Complete Suppression of Severe Acne
Prolong remission o severe acne.
Added advantage of Grape Seed Extract an OPC (Oligomeric Proanthocyanidines) Flavanoid which is 50 times more potent than Vit E and 20 times more potent than Vit C
Scavenges free radicals released during acne
Heals faster and reduces scar formation

CLINICAL PHARMACOLOGY

Isotretinoin (13-cis-retinoic acid) is the only anti-acne agent that affects all four of the known major etiologic mechanisms: sebum production, comedogenesis, Propionobacterium acnes, colonization of ductal and skin surface, and monocyte chemotaxis-induced inflammation. This may explain its unique ability to sustain long-term treatment-free remissions and, in some cases, a permanent remission or “cure” can be achieved.

Grape seed extract is a natural plant substance that has a concentrated source of oligomeric proanthocyanidins (OPC). These antioxidants help protect cells from free radical damage, while promoting healthy circulation.

INDICATIONS AND USAGE

Isotretinoin is used in severe acne or any acne that causes scarring.

CONTRAINDICATIONS

Pregnancy Category X : Isotretinoin must not be used by females who are pregnant or who may become pregnant while undergoing treatment.
This drug is contraindicated in individuals with a history of sensitivity reactions to any of its components

PRECAUTIONS

Effective contraception must be used for at least one month before beginning isotretinoin therapy, during therapy, and for one month following
discontinuation of therapy even when there has been a history of infertility, unless due to hysterectomy.

It is strongly recommended that prescription for isotretinoin should not be given
until a female patient has had negative results from two urine or seru pregnancy tests.

Isotretinoin may cause depression, psychosis and, rarely, suicidal ideation, suicide attempts, suicide, and aggressive and/or violent behaviors. No
mechanism of action has been established for these events

Elevations of serum triglycerides in excess of 800 mg / dl have been reported in patients treated with isotretinoin.

Laboratory Tests

Pregnancy test :
Female patient of child bearing potential must have negative results from two urine or serum pregnancy tests.
Lipids : Pretreatment and follow up blood lipids should be obtained under fasting conditions.

Liver function test:
Pretreatment and follow up liver function tests blood should be performed.

Glucose:
Loss of control in blood sugar has been observed in patients receiving isotretinoin

Serum creatinine:
Elevations of serum creatinine has been observed.

Drug Interactions:
Following drug should be avoided when taken together with isotretinoin: Aluminum-containing antacids, Alcohol, Benzoyl peroxide, Corticosteroids (example; prednisone), progestin-only birth control hormones. Tetracycline antibiotics and other drugs than can cause sun-sensitivity and Vitamin A. Caution should also be exercised with phenytoin and systemic corticosteroids.

Carcinogenesis, Mutagenesis, and Impairment of Fertility:
In rats, no adverse effects on gonadal function, fertility, conception rate,
gestation or parturition were observed at oral dosages of isotretinoin of 2, 8
or 32 mg.kg.day.

Pregnancy:
Isotretinoin is contraindicated in females of childbearing potential.

Teratogenic Effects:
Isotretinoin is highly teratogenic.

Nursing Mothers:
It is not known whether this drug is excreted in human milk. Because of the potential for adverse effects, nursing mothers should not receive isotretinoin.

Pediatric Use:
The use of isotretinoin below 12 years of age has not been studied.

Geriatric Use:
Effects of aging might be expected to increase some risks associated with isotretinoin therapy.

ADVERSE REACTIONS

Common mucocutaneous adverse effects are red, cracked, and sore lips. red, itchy, dry, and inflamed eyes. Dry mouth,nose and skin.

Abnormal Laboratory Parameters:

Elevation in liver enzymes has been observed in clinical trials with isotretinoin.
Elevation of plasma triglycerides,decrease in HDL level,elevation of serum cholesterol
Increased alkaline phosphatase,SGOT,SGPT,GGTP or LDH
Elevation of fasting blood sugar, CPK
Cheilitis and hypertriglyceridemia are usually dose related. Other adverse effects:
Cardiovscular: palpitation, tachycardia, vascular thrombotic disease, stroke
Musculoskeletal: skeletal hyperosteosis, calcificatoion of tendons and ligaments, arthralgia.
Neurological: dizziness, drowsiness, headace, insomnia seizures, stroke
Psychiatric: suicide, depression, pyschosis
Reproductive: abnormal menses
Respiratory: bronchospasm
Urinary system: glomerulonephritis
Most adverse effects reported in clinical trials are reversible when therapy is discontinued.

DOSAGE AND ADMINISTRATION

Isotretinoin should be administered with a meal.
The recommended dosage range for Isotretinoin is 0.5 to 1.0 mg/kg/day
given in two divided doses with food for 15 to 20 weeks.

OVERDOSAGE

In humans, overdosage has been associated with vomiting, facial flushing, cheilosis, abdominal pain, headache, dizziness, and ataxia. All symptoms quickly resolved without apparent residual effects.

1. What is ISOACE?
A: It is a combination of Isotretinoin and Grape Seed Extract for the treatment of severe acne. Isotretinoin is in a class of drugs called retinoids. It is used to treat severe acne that has not responded to oral or
topical anti-infectives.

Grape Seed Extract an oligomerisc proanthocyanidine flavanoid is a
potent antioxidant.

2. What is the active ingredient?
A: Isotretinoin : 20 mg
Grape Seed Extract : 25 mg

3. How is it available?
A: Available as soft gelatin capsules in a strip of 10’s to be taken by orally by
mouth.

4. What are its indications or uses?
A: Isoace is used in severe acne or any acne that causes scarring.

5. What is the right dosage?
A: Isoace usually is taken twice a day. Take with food or milk. Take Isoace
exactly as directed. Do not change the dosage, other than that prescribed
by your dermatologist.

6. What is to be done in case of a missed dosage?
A: Take the missed dose as soon as you remember it. However, if it is
almost time for the next dose, skip the missed dose and continue your
regular dosing schedule. Do not take a double dose to make up for a
missed one.

7. What are the precautions while taking the Isoace?
A: Isotretinoin can harm the fetus. It can also cause miscarriage, premature birth, or death of the baby. Tell your doctor if you are pregnant, plan to becomepregnant, or are breast-feeding.

If you become pregnant while taking Isotretinoin, stop taking

Isotretinoin and call your doctor immediately.

Use two reliable methods of birth control for 1 month before taking,

while taking, and for 1 month after stopping to take this drug

See your doctor if you become depressed, experience changes in mood like feeling sad, crying spells, changes in your normal sleep pattern, becoming more irritable and aggressive and withdrawal from family and friends

Tell your doctor if you are allergic to isotretinoin, parabens, or any other drugs.

Do not take any vitamin supplements that contain vitamin A to avoid possible harmful reactions.

Tell your doctor if you have or have ever had diabetes, liver disease, pancreatitis, a high amount of triglycerides (fats) in your blood, a family history of high triglycerides in the blood, or depression.

Plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen. Isotretinoin may make your skin sensitive to sunlight.

Be aware that this medicine may affect your night vision. Be cautious when driving or operating any machinery after dark.

Hair removal by waxing and laser procedures to the skin should be avoided while taking isotretinoin and for 6 months after stopping isotretinoin. These procedures may cause scarring.

8. Which drugs should be avoided along with it ?
A: Do not take any vitamin supplements that contain vitamin A to avoid possible harmful reactions.
Isotretinoin may cause intracranial hypertension, especially when it is taken with tetracycline.

9. Who cannot take the medicine?
A: Pregnant Women or who plan to be pregnant

Nursing mothers

Children below 12 years of age

10.What is the time of taking the medicine, dosage and the usual duration?
A: Isotretinoin usually is taken twice a day. Take isotretinoin with food or milk.Take isotretinoin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

11.What are the possible common and rare adverse effects of the medicine?
A: Some less serious side effects from isotretinoin are common.Tell your
doctor if any of these symptoms are severe or do not go away:
Red, cracked, and sore lips
Red, itchy, dry, and inflamed eyes
Dry mouth and nose
Dry skin
Thinning of the hair
Fatigue
If you experience any of the following symptoms call your doctor
immediately:
Bone Or Joint Pain
Chest Pain
Dizziness
Stomach Pain
Headache
Upset stomach
Vomiting
Difficulty with vision
Difficulty breathing or swallowing
Difficulty hearing
Ringing in your ears
Difficulty walking
Rectal bleeding
Severe diarrhea
Bruising or red patches of the skin
Muscle aches
Skin peeling
Skin infections
Depression
Seeing visions or hearing voices that do not exist

psorvate-ointment

12.How to store the medicine?
A: Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

13. What is the Price per unit?
A: Isoace capsules – Strip 10’s –Rs. 350/-