Generic Name:Thalidomide

Thalidomide is prescribed drug used for leprosy. It was approved in Europe in 1957, but was rejected for approval in the United States because of concerns about neuropathy associated with use of the drug. While the Agency was awaiting answers to these concerns, the link between thalidomide use and an epidemic of congenital malformations was recognized and the drug was then withdrawn form marketing. This medication is used to treat or prevent certain skin conditions related to Hansen's disease, once known as leprosy erythema nodosumleprosum. Thalidomide is also used with other drugs to treat a certain type of cancer known as multiple myeloma.

Because of the toxicity of this drug and in an effort to make the chance of fetal exposure to Thalidomide as negligible as possible, it will be approved for marketing only under a special restricted distribution program approved by the FDA. This program is called the "Steps for Thalidomide education and Prescribing Safety" or steps. Under this restricted distribution program, only prescribers and pharmacists registered with the program are allowed to prescribe and dispense the product.

How to Use Thalidomide Capsules

  • Take this medication by mouth with water, usually once daily at bedtime at least 1 hour after the evening meal or as directed by your doctor.
  • Dosage is based on your medical condition and response to treatment. Do not increase your dose or take this medication more often than prescribed.
  • Your condition will not improve any faster, and the risk of serious side effects may be increased.
  • Keep the capsules in their blister pack until ready to use. If any of the powder from the capsule gets on your skin, wash the area with soap and water.

Cautions before use Thalidomide Capsules

  • This medication should not be used if you have a certain medical condition. Before using this medicine, consult your doctor or pharmacist if you have: a certain immune system problem like neutropenia.
  • Before using this medication, tell your doctor or pharmacist your medical history, especially of: numbness/tingling of arms or legs, seizures.
  • Before taking Thalidomide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
  • Thalidomide may cause possibly severe nerve damage, which may be permanent. This may occur during treatment or after treatment has stopped.
  • A very serious allergic reaction to this drug can appear with Thalidomide.
  • Women who are pregnant must not use Thalidomide

Thalidomide Capsules Side Effects

The side effects which may arise due to the usage of Thalidomide are as follows:

  • Birth defects
  • Drowsiness and somnolence
  • Peripheral neuropathy
  • Dizziness and orthostatic hypotension
  • Neutropenia
  • Increased HIV-Viral load
  • Hypersensitivity and Bradycardia
  • Enhanced sedative activity of barbiturates

Reactions and Overdose of Thalidomide Capsules

Thalidomide may react with drugs that may cause nerve damage such as certain HIV drugs including didanosine/zalcitabine, certain cancer drugs including paclitaxel, cisplatin, vincristine, quinolone antibiotics such as ciprofloxacin.

Symptoms of overdose may include prolonged sleep which may happen with Thalidomide.


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