Drug Information

Drug Interaction:

Interacting drugs- summary

Stavudine +

Indinavir coadmin resulted in a 25% increase in stavudine AUC

Drug/Food interaction: Cmax of stavidine was decreased by about 45% when administered with food.

Indication:

HIV infection

Approved by FDA on June 24,1994

LIST OF DRUGS DURING 2006

Sr.No- 115

Name of the Drug- Stavudine SR 100mg tablet Pharmacological Classification- Anti HIV

Date of Approval- 29-08-2006

Approved by U.S.FDA on 30-12-2006 (Ref- FDA approved List)

New Drugs Approved by (DCI) Drug Controller GENERAL - India For Marketing

(Ref- IDMA Publication)

Name of Drug Indication Date of Approval

1.Stavudin HIV/AIDS July 1997

2.Stavudin ER 100mg tablet ANTI-HIV 29-08-2006

FIXED DOSE COMBINATIONS APPROVED BY DCG(I)

FROM JANUARY 1961 TILL NOVEMBER 2014

Name of Drug Indication Date of Approval

1.Combikit of 2 tablet of Stavidine 40mg + 06-07-2005

Lamivudine 150mg each and

1 tablet of Efavirenz 600mg

For HIV infection in adults

2.Combikit of 2 tablets of Stavudine 30mg/40mg + 22-11-2004

Lamivudine 150mg/150mg &

1 Tablet of Nevirapine 200mg

For HIV infection in adults who have been stabilised on the

maintenance regimen of Nevirapine 200mg BD and have

demonstrated adequate tolarability to Nevirapine

3.Stavudine 10mg + 11-11-2005

Lamivudine 40mg +

Nevipramine 70mg dispersible tablet

For the treatment of HIV infectiom

4. Stavudine 30mg/40mg + 26-07-2001

Lamivudine 150mg/150mg +

Nevipramine 200mg/200mg tablet

HIV infection in adult patients . Once patients have been

stabilised on the maintenance regimen of nevipramine 200

mg BD and have demonastrated adequat toleralbility

to Nevipramine

5.Stavudine 6mg/12mg + 08-05-2005

Lamivudine 30mg/60mg dispersible tablet

for the treatment of HIV infection in children

Patent Expiry Date of drugs (Ref - IDMA Publication)

Chemical Category Manufacturer/ US Patent

Ingredient- Marketer Expiration Date

Stavudin HIV/AIDS Bristol-Meyers Squibb 24-06-2008

Adverse Reaction:

Headache, chills/fever, Asthenia, abdominal pain, Back pain, malaise, weight loss, Allergic reaction. Chest pain, vasodilation, Hypertension. Insomnia, anxiety, Neuropathy.

Contra-Indications:

Hypersensity to the drug

Special precautions:

Mild to moderate increases in AST and ALT occured commonly in clinical trials.

Dosages/ Overdosage Etc:

Approved by FDA on June 24,1994

Indications: HIV infection

Dosage: Adults- Patients more than 60kg- 40mg twice daily

Patients below 60kg- 30mg twice daily.

Patient Information:

1. Inform patients that Stavudine is not not a cure for HIV infection, and that they

may continue to acquire illness associated with AIDS or ARC.

2. Inform patients that the most common toxicity of Stuvudine is peripheral

neuropathy, symptoms include tingling, burning, pain or numbness in the

hands and feet.

3. Tell patients that long term effects of stavudine are not known at this time.

Ref - USP PDI Vol II 17th Edition (1997)

STAVUDINE - SYSTEMIC

1.Allergies-

Tell your doctor if you have ever had any unusual or allergic reaction to

Stavudine. Also tell your healthcare care professional if you are allergic

to any other substances such as foods. preservatives or dyes.

2.Pregnancy-

Studies have not been done in pregnant wome. However, studies in animals

have not shown that stavudine causes birth defects when given in very given

in very high doses. Before taking this medicine, make sure your doctor knows

if you are pregnant or if you become pregnant.

3. Breast-feeding-

It is not known whether stavudine passes into breast milk. However, if your

baby does not already AID virus , there is a chance that you could pass it

on to your baby by breast- feeding. Talk to your doctor first if you are

thinking about breast-feeding your baby.

4.Children-

Studies of this medicine has been done only in adult patients and there

is no specific information comparing use of stavudine in children with

use in other age groups.

5.Older adults-

Studies have not been done in older people. Therefore, it is not known

whether it causes different side effects in the elderly than it does

in younger adults.

6. Other medicines-

Tell your doctor if you taking any of the following medicines.

Chloramphenicol or

Cisplatin or

Dapsone or

Ethambutol or

Ethionamide or

Hydralzine or

Isoniazid or

Lithium or

Metronidazole or

Nitrofurantoin or

Phenytoin or

Vincristine or

Zalcitabine - use of these medicines with stavudine may decrease

the chance of peripheral neuropathy (tingling,burning, numbness,

or pain in your hands or feet.)

7. Other medical problems-

Make sure you tell your doctor if you have any other medical problems

especially-

Alcohol abuse, active or a history of or

Liver disease - stavudine may make the liver disease, active alcohol

abuse, or a history of alcohol abuse.

Kidney disease - patients with kidney disease may have an increased

chance of side effects

Peripheral neuropathy - stavudine may make the condition worse.

Pharmacology/ Pharmacokinetics:

Pharmacology:

Stavudine is a synthetic thymidine nuleoside analog active against the human immunoefficiency virus (HIV). It inhibits the replication of HIV in human cells in vitro.

Pharmacokinetics:

Folowing oral admin, Stavudine is rapidly absorbed with a mean absolute bioavailability of 86.4%

Interaction with Food:

Drug/Food interaction: Cmax of stavidine was decreased by about 45% when administered with food.

Pregnancy and lactation:

Pregnancy: Use during pregnancy only if clearly needed.

Lactation: Instruct mothers to discontinue nursing if they are receiving stavidine

Stavudine - @- Antiviral agent - ( FDC- List )- (June 1994)

Drug Interaction

Indication

Adverse Reaction

Contra-Indications

Dosages/ Overdosage Etc

Patient Information

Pharmacology/ Pharmacokinetics

Interaction with Food

Pregnancy and lactation