Type:strong:capsule:Manufacturer.Distributor:incepta pharmaceuticals Ltd.
Generic neame: Thalidomide
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Midothal is used in the treatment of multiple myeloma and lepra reaction. This medicine belongs to a group of medicines which affect how your immune system works. Midothal should be taken on empty stomach, but try to have it at the same time every day to get the most benefits. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to. Some common side effects of this medicine include headache, sleepiness, nausea, rash, and breathlessness. This medicine may reduce the number of blood cells (decrease red blood and white blood cells) in your blood, thereby, increasing the susceptibility to infections or bleeding. Regular blood tests are required to check your blood cells while on treatment. It might cause blood clots, and your doctor might prescribe some other medicine to prevent this. Before taking it, tell your doctor if have heart disease, liver, or kidney problems. Many other medicines can affect, or be affected by, this medicine so let your healthcare team know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. The use of effective contraception by both males and females during treatment is important to avoid pregnancy. You are advised to drink plenty of fluids to stay hydrated while taking this medicine.
Uses of Midothal
Side effects of Midothal
How to use Midothal
Take this medicine in the dose and duration as advised by your doctor. Do not chew, crush or break it. Midothal is to be taken empty stomach.
How Midothal works
Midothal modulates the activity of body's immune system and helps indirectly attacking the cancer cells. It also stops the growth of blood vessels in cancer.
What if you forget to take Midothal?
If you miss a dose of Midothal, 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 schedule. Do not double the dose.
Quick Tips
Use an effective method of contraception for 4 weeks before starting treatment, during treatment, and until 4 weeks after stopping treatment.
Before taking thalidomide inform your doctor if you have had a heart attack, have ever had a blood clotting related disorder, or if you smoke, have high blood pressure or high cholesterol levels, have existing slow heart rate (this may be symptoms of bradycardia), existing neuropathy i.e. tingling, abnormal co-ordination or pain in your hands or feet, sleepiness, a condition called Tumor Lysis Syndrome, severe infections.
Consult a doctor if you develop allergic reaction such as rash, itching, swelling, dizziness or trouble breathing during thalidomide therapy.
Avoid donating blood during thalidomide treatment and for 1 week after stopping treatment.
Do not drive or operate machinery as thalidomide may cause fatigue, dizziness, somnolence and blurred vision.
Tell your doctor if you are or planning to become pregnant or are breastfeeding.
Indication
Administration
Should be taken on an empty stomach. Take on an empty stomach at least 1 hr after a meal, w/ a full glass of water.
Adult Dose
Oral Erythema nodosum leprosum (Type 2) Adult: 100-300 mg once daily at bedtime, reduced gradually by 50 mg every 2-4 wk once a satisfactory reponse is achieved. Not for monotherapy if moderate or severe neuritis present. Max: 400 mg/day. Patients < 50 kg: Initially, 100 mg daily. Multiple myeloma Adult: Initial dose of 200 mg once daily, increased by 100 mg at wkly intervals according to patient tolerance. Max: 800 mg daily.
Contraindication
Hypersensitivity. Pregnancy and lactation.
Mode of Action
Thalidomide is a synthetic glutamic acid derivative immunomodulator with anti-inflammatory, antiangiogenetic, sedative, and hypnotic activity.
Precaution
All females of childbearing potential must use 2 reliable forms of contraception simultaneously 4 wk before starting therapy, during and 4 wk after therapy is discontinued. Therapy to be stopped immediately if pregnancy occurs. Male: Use of barrier methods of contraception if partner is of child-bearing potential. Do not donate blood or sperm during therapy. Patient should not drive or operate machinery. Discontinue therapy if any skin rash develops. Do not resume therapy if the rash is exfoliative, purpuric, or bullous, or if Stevens-Johnson syndrome or toxic epidermal necrolysis suspected. Lactation: not known if excreted in breast milk, not recommended
Side Effect
>10% Somnolence (37%),Rash (21%),Edema (57%),Hypotension (16%),Leukopenia (17-35%),Neutropenia (31%),Increased bilirubin (14%),Myalgia (17%),Arthralgia (13%),Hematuria (11%),Thrombosis/embolism (23%),Headache (12%),Dyspnea (42%) 1-10% Asthenia (8%),General pain (8%),Impotence (8%),Malaise (8%),Pruritus (8%),Xerostomia (8%),Flatulence (8%),Tooth pain (4%),Impotence (3-8%),Vertigo (8%),Constipation (4%),Diarrhea (4%),Neck rigidity (4%) Frequency Not Defined Photosensitivity,Bradycardia,Hypo/hypertension,Peripheral neuropathy,Neutropenia Potentially Fatal: Stevens-Johnson syndrome, toxic epidermal necrolysis and blood dyscrasias.
Interaction
Thalidomide enhances sedative activity of barbiturates, alcohol, chlorpromazine and reserpine. Avoid use of other drugs that have the potential to cause peripheral neuropathy. Increased risk of thromboembolic events with darbepoetin-alfa and doxorubicin. Potentially Fatal: Increased risk of bone marrow supression with peg interferon alfa.
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