Carbadura tablets

Carbadura

  • Active Ingredient: Carbamazepine
  • 400 mg, 200 mg, 100 mg
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What is Carbadura?

The active ingredient of Carbadura brand is carbamazepine. Carbamazepine is an anticonvulsant. It works by decreasing nerve impulses that cause seizures and pain.

Used for

Carbadura is used to treat diseases such as: Bipolar Disorder, Borderline Personality Disorder, Cluster-Tic Syndrome, Cyclothymic Disorder, Diabetic Peripheral Neuropathy, Dystonia, Epilepsy, Occipital Neuralgia, Peripheral Neuropathy, Reflex Sympathetic Dystrophy Syndrome, Schizoaffective Disorder, Trigeminal Neuralgia, Vulvodynia.

Side Effect

Possible side effects of Carbadura include: sudden, wide mood swings; other problems with muscle control or coordination; pain, tenderness, swelling, or bluish color in the leg or foot; shakiness and unsteady walk; increased sweating.

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How much will I take?

How much you take will depend on what you are taking it for.

You'll usually start on a low dose of 100mg to 200mg, taken once or twice a day. This will be increased over several weeks to the usual dose.

For:

  • epilepsy - 800mg to 1200mg, taken as 1 or 2 doses
  • nerve pain - 600mg to 800mg, taken as 1 or 2 doses
  • bipolar disorder - 400mg to 600mg, taken as 1 or 2 doses

In children, the dose of Carbadura will depend on the weight of your child. Your doctor will be able to prescribe the right dose for your child.

Antibiotics

Taking certain antibiotics with Carbadura will increase the level of Carbadura in your body. This can cause side effects. Your doctor may monitor your blood levels of Carbadura if you’re taking it with one of these drugs:

  • clarithromycin
  • erythromycin
  • ciprofloxacin

HIV drugs

Taking certain HIV medications with Carbadura will increase the level of Carbadura in your body. This can cause side effects. Your doctor may monitor your blood levels of Carbadura if you’re taking it with one of these drugs:

Will my dose go up or down?

To prevent the chance of side effects, your doctor will start you off on a low dose of Carbadura. They will increase it gradually over a few days or weeks.

Once you find a dose that suits you, it will usually stay the same - unless your condition changes, or your doctor starts you on a new medicine that may affect Carbadura.

Cautions

Monitor for notable changes in behavior that might indicate suicidal thoughts or depression and notify healthcare provider immediately if behavioral changes observed

Discontinue if significant bone marrow depression occurs

Increased risk of agranulocytosis and aplastic anemia

May cause ECG abnormalities; use caution in patients with conduction abnormalities; AV heart block, including second and third degree block, reported following Carbadura treatment; effect occurred generally, but not solely, in patients with underlying EKG abnormalities or risk factors for conduction disturbances

May exacerbate absence seizures; in the event of allergic or hypersensitivity reaction, more rapid substitution of alternative therapy may be necessary

Bipolar mania: Efficacy inconsistent; APA recommends use after failure of or if there is resistance to lithium and valproate

May cause psychosis/confusion/agitation; elderly patients are at greater risk

May render oral contraceptives ineffective

Higher risk of potentially fatal skin reactions (SJS/TEN) in patients of Asian ancestry (genetic testing recommended); increased risk of developing hypersensitivity reactions with presence of HLAA*3101 or HLA-B*1502, inherited allelic variants of the HLA-A and HLA-B gene (see Pharmacogenomics in the Pharmacology section);

Hyponatremia may occur and appears to be a result of SIADH; may be dose-related and elderly individuals are at greater risk

Associated with hypotension, bradycardia, AV block, and signs and symptoms of HF

Fatal dermatologic reactions, including toxic epidermal necrolysis (TEN) and Stevens-Johnson syndrome (SJS), reported

Not a simple analgesic; do not use to relieve minor aches and pains

Suspension formulation contains sorbitol; not for administration to patients with rare hereditary problems of fructose intolerance

AV heart block, including second and third degree block, reported following Carbadura treatment; effect occurred generally, but not solely, in patients with underlying EKG abnormalities or risk factors for conduction disturbances

Rare cases of anaphylaxis and angioedema involving larynx, glottis, lips, and eyelids reported with first or subsequent doses; angioedema associated with laryngeal edema can be fatal; if a patient develops reactions after treatment discontinue therapy and start alternative treatment; patients should not be rechallenged with drug

Mild anticholinergic activity; use caution in patients with snesitivity to anticholinergic effects

Endocrine

Very rare (less than 0.01%): Increase in prolactin (with or without symptoms such as gynecomastia or galactorrhea), impaired male fertility and/or abnormal spermatogenesis, abnormal thyroid function tests (e.g., decreased L-thyroxine and increased TSH)

Frequency not reported: Lower serum testosterone, lower free androgen indexes, increased cerebrospinal fluid thyrotropin-releasing hormone levels

Carbadura increases the rate of T4 and T3 metabolism and may lead to hypothyroidism in patients with hypothyroidism who are being treated with T4. Carbadura may also cause a 20% to 40% decrease in serum total and free T4 concentrations and a smaller decrease in serum total and free T3 concentrations in patients who have no thyroid disease.

COMMON BRAND(S): Tegretol

GENERIC NAME(S): Carbadura

Carbadura may rarely cause very serious (possibly fatal) skin reactions. Some people in certain ethnic groups (such as people of Asian/South Asian descent) are at greater risk. Your doctor may order a blood test to measure your risk before you start this medication. If the blood test shows you are at greater risk, your doctor should discuss the risks and benefits of Carbadura and other treatment choices with you. Such skin reactions have developed mostly within the first few months of treatment. Get medical help right away if you develop any of the following symptoms: skin rash/blisters/peeling, itching, or swelling. Ask your doctor or pharmacist for more details.

This drug has rarely caused very serious blood disorders (aplastic anemia, agranulocytosis). Your doctor will monitor your blood counts to minimize the chance of these side effects. Keep all medical and lab appointments. Get medical help right away if any of these rare but very serious side effects occur: signs of infection (such as sore throat that doesn't go away, fever, swollen lymph nodes), unusual weakness/tiredness, shortness of breath, or easy bleeding/bruising.

Carbadura is used to prevent and control seizures. This medication is known as an anticonvulsant or anti-epileptic drug. It is also used to relieve certain types of nerve pain (such as trigeminal neuralgia). This medication works by reducing the spread of seizure activity in the brain and restoring the normal balance of nerve activity.

Carbadura side effects

Get emergency medical help if you have signs of an allergic reaction to Carbadura (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes. Symptoms may occur several weeks after you start using Carbadura.

Report any new or worsening symptoms to your doctor, such as: sudden mood or behavior changes, depression, anxiety, insomnia, or if you feel agitated, hostile, restless, irritable, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have:

a skin rash, no matter how mild;

loss of appetite, right-sided upper stomach pain, dark urine;

slow, fast, or pounding heartbeats;

anemia or other blood problems - fever, chills, sore throat, mouth sores, bleeding gums, nosebleeds, pale skin, easy bruising, unusual tiredness, feeling light-headed or short of breath; or

low levels of sodium in the body - headache, confusion, severe weakness, feeling unsteady, increased seizures.

Common Carbadura side effects may include:

dizziness, loss of coordination, problems with walking;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I take Carbadura?

Take Carbadura exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Swallow the extended-release tablet or capsule whole and do not crush, chew, or break it. Tell your doctor if you cannot swallow a pill whole.

The chewable tablet must be chewed before you swallow it.

Shake the oral suspension (liquid) before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and call your doctor promptly if this medicine seems to stop working as well in preventing your seizures.

You will need frequent medical tests.

Store at room temperature away from moisture, heat, and light.

Do not stop using Carbadura suddenly, even if you feel fine. Stopping suddenly may cause increased seizures. Follow your doctor's instructions about tapering your dose.

How to take it

If you take Carbadura twice a day, try to space your doses evenly through the day. For example, first thing in the morning, and in the evening. You can take it with or without food.

Tablets - you can take tablets with or without food. Swallow the tablets whole with a drink of water. The tablets have a score line to help you break the tablet in half if you have difficulties swallowing the tablet whole.

Liquid - to take carbamezapine liquid shake the bottle before you measure out your dose. The medicine will come with a plastic syringe or spoon to help you measure out the right dose. If you don't have one, ask your pharmacist for one. Do not use a kitchen teaspoon as it will not give the right amount.

Suppositories - take the wrapping off and push a suppository gently into your anus. Read the instructions in the leaflet inside the package. They will explain how to use the suppository.

International Brand Names

Log on to ExpertConsult.com for a list of all international brand names.

Apo- Carbadura (Canada, Malaysia); Camapine (Taiwan, Thailand); Carbatol (India); Carbazene (Thailand); Carbazep (Mexico); Carbazina (Mexico); Carmaz (India); Carpaz (South Africa); Carzepin (Malaysia); Carzepine (Thailand); Clostedal (Mexico); Degranol (South Africa); Epileptol (Korea); Epileptol CR (Korea); Eposal Retard (Colombia); Espa-lepsin (Germany); Foxalepsin (Germany); Foxalepsin Retard (Germany); Hermolepsin (Sweden); Karbamazepin (Sweden); Kodapan (Japan); Lexin (Japan); Mazetol (India, Malaysia); Neugeron (Costa Rica, Dominican Republic, Guatemala, Honduras, Mexico, Nicaragua, Panama); Neurotol (Finland); Neurotop (Austria, Hungary, Malaysia); Neurotop Retard (Malaysia); Nordotol (Denmark, Mexico); Panitol (Thailand); Sirtal (Germany); Tardotol (Denmark); Taver (Thailand); Tegol (Taiwan); Tegretal (Germany); Tegretol CR (Israel, Korea, New Zealand, South Africa); Tegretol-S (South Africa); Telesmin (Japan); Temporal Slow (Hungary); Temporol (Bulgaria, South Africa); Teril (Hong Kong, Israel, New Zealand, Taiwan); Timonil (Germany, Israel); Timonil Retard (Germany, Israel, Switzerland)

6. How to cope with s >

What to do about:

  • feeling sleepy, dizzy or tired - do not drive or use tools or machinery if you're feeling this way. Try to avoid drinking alcohol as this will make you feel more tired. If you feel dizzy, stop what you are doing and sit or lie down until you feel better. As your body gets used to Carbadura, these side effects should wear off. If they don't go after a few weeks, speak to your doctor.
  • feeling or being sick - stick to simple meals and do not eat rich or spicy food while you're taking this medicine. It might help to take your Carbadura after you've had a meal or snack. If you're being sick, try having small, frequent sips of water or squash to avoid dehydration. Do not take any other medicines to treat vomiting without speaking to a pharmacist or doctor.
  • headaches - make sure you rest and drink plenty of fluids. Do not drink too much alcohol. Ask your pharmacist to recommend a painkiller. Talk to your doctor if headaches last longer than a week or are severe.
  • dry mouth - try chewing sugar-free gum or sucking sugar-free sweets.
  • putting on weight - try to eat a healthy balanced diet without increasing your portion sizes. Do not snack on foods that contain a lot of calories, such as crisps, cakes, biscuits and sweets. If you feel hungry between meals, eat fruit and vegetables and low-calorie foods. Regular exercise will also help to keep your weight stable.

CONTRAINDICATIONS

Tegretol should not be used in patients with a history of previous bone marrow depression, hypersensitivity to the drug, or known sensitivity to any of the tricyclic compounds, such as amitriptyline, desipramine, imipramine, protriptyline, nortriptyline, etc. Likewise, on theoretical grounds its use with monoamine oxidase (MAO) inhibitors is not recommended. Before administration of Tegretol, MAO inhibitors should be discontinued for a minimum of 14 days, or longer if the clinical situation permits.

Coadministration of Carbadura and nefazodone may result in insufficient plasma concentrations of nefazodone and its active metabolite to achieve a therapeutic effect. Coadministration of Carbadura with nefazodone is contraindicated.

Nursing Mothers

Tegretol and its epoxide metabolite are transferred to breast milk. The ratio of the concentration in breast milk to that in maternal plasma is about 0.4 for Tegretol and about 0.5 for the epoxide. The estimated doses given to the newborn during breastfeeding are in the range of 2 to 5 mg daily for Tegretol and 1 to 2 mg daily for the epoxide.

Because of the potential for serious adverse reactions in nursing infants from Carbadura, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Urgent advice: Call a doctor straight away if you take too much Carbadura and:

  • feel sick or be sick (vomit)
  • have breathing problems
  • feel dizzy or sleepy
  • have difficulty talking
  • your vision is blurred
  • have stomach pain
  • feel confused, or your normal behaviour changes
  • pass out

If you need to go to A&E, do not drive yourself - get someone else to drive you or call for an ambulance. Take the carbamezapine packet or leaflet inside it plus any remaining medicine with you.

Like all medicines, Carbadura can cause side effects, although not everyone gets them.


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