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What is the most important information I should know about Becalm?
Do not use this medication if you are allergic to Becalm or to other benzodiazepines, such as Becalm (Xanax), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax).
This medication can cause birth defects in an unborn baby. Do not use Becalm if you are pregnant.
Before taking Becalm, tell your doctor if you have any breathing problems, glaucoma, porphyria, kidney or liver disease, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.
Do not drink alcohol while taking Becalm. This medication can increase the effects of alcohol.
Tell your doctor if you regularly use other medicines that make you sleepy. They can add to sleepiness caused by Becalm.
Becalm may be habit-forming and should be used only by the person it was prescribed for. Becalm should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.
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What are the possible side effects of Becalm?
The necessity of discontinuing therapy because of undesirable effects has been rare. Drowsiness, ataxia and confusion have been reported in some patients particularly the elderly and debilitated. While these effects can be avoided in almost all instances by proper dosage adjustment, they have occasionally been observed at the lower dosage ranges. In a few instances syncope has been reported.
Other adverse reactions reported during therapy include isolated instances of skin eruptions, edema, minor menstrual irregularities, nausea and constipation, extrapyramidal symptoms, as well as increased and decreased libido. Such side effects have been infrequent, and are generally controlled with reduction of dosage. Changes in EEG patterns (low-voltage fast activity) have been observed in patients during and after Becalm (Becalm) treatment.
Blood dyscrasias (including agranulocytosis), jaundice and hepatic dysfunction have occasionally been reported during therapy. When Becalm (Becalm) treatment is protracted, periodic blood counts and liver function tests are advisable.
DRUG ABUSE AND DEPENDENCE: Becalm hydrochloride capsules are classified by the Drug Enforcement Administration as a Schedule IV controlled substance.
Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuance of Becalm. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (eg, dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving Becalm or, other, psychotropic agents because of the predisposition of such patients to habituation and dependence.
Becalm (Becalm) is indicated for the management of anxiety disorders or for the short term relief of symptoms of anxiety, withdrawal" symptoms of acute alcoholism, and preoperative apprehension and anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.
The effectiveness of Becalm (Becalm) in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.
Becalm is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Becalm affects chemicals in the brain that may become unbalanced and cause anxiety.
Becalm is used to treat anxiety disorders or alcohol withdrawal.
Becalm may also be used for other purposes not listed in this medication guide.
A carbamate with hypnotic, sedative, and some muscle relaxant properties, although in therapeutic doses reduction of anxiety rather than a direct effect may be responsible for muscle relaxation. Becalm has been reported to have anticonvulsant actions against petit mal seizures, but not against grand mal seizures (which may be exacerbated). It is used in the treatment of anxiety disorders, and also for the short-term management of insomnia but has largely been superseded by the benzodiazepines. (From Martindale, The Extra Pharmacopoeia, 30th ed, p603) Becalm is a controlled substance in the U.S.
Use Becalm injection as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Becalm injection.
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.Becalm is used to treat anxiety and acute alcohol withdrawal. It is also used to relieve fear and anxiety before surgery. This medication belongs to a class of drugs called benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming effect. It works by enhancing the effects of a certain natural chemical in the body (GABA).
How to use BecalmTake this medication by mouth as directed by your doctor. The dosage is based on your age, medical condition, and response to treatment.
Use this medication exactly as prescribed. Do not increase your dose, take it more frequently or use it for a longer period of time than prescribed because this drug can be habit-forming. Also, if used for an extended period of time, do not suddenly stop using this drug without your doctor's approval. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased to avoid side effects such as seizures.
When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.
Because of the wide range of clinical indications for Becalm (Becalm), the optimum dosage varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects.
| ADULTS | USUAL DAILY DOSE |
| Relief of Mild and Moderate Anxiety Disorders and Symptoms of Anxiety | 5 mg or 10 mg, 3 or 4 times daily |
| Relief of Severe Anxiety Disorders and Symptoms of Anxiety | 20 mg or 25 mg, 3 or 4 times daily |
| Geriatric Patients, or in the presence of debilitating disease. | 5 mg, 2 to 4 times daily |
Preoperative Apprehension and Anxiety: On days preceding surgery, 5 to 10 mg orally, 3 or 4 times daily. If used as preoperative medication, 50 to 100 mg IM* 1 hour prior to surgery.
| PEDIATRIC PATIENTS | USUAL DAILY DOSE |
| Because of the varied response of pediatric patients to CNS-acting drugs, therapy should be initiated with the lowest dose and increased as required. Since clinical experience in pediatric patients under 6 years of age is limited, the use of the drug in this age group is not recommended. | 5 mg, 2 to 4 times daily (may be increased in some pediatric patients to 10 mg, 2 to 3 times daily) |
For the relief of withdrawal symptoms of acute alcoholism, the parenteral form* is usually used initially. If the drug is administered orally, the suggested initial dose is 50 to 100 mg, to be followed by repeated doses as needed until agitation is controlled up to 300 mg per day. Dosage should then be reduced to maintenance levels.
* See package insert for Injectable Becalm (Becalm HCI).
How suppliedBecalm (Becalm HCI) Capsules are available in the following presentations:
5 mg hard gelatin capsules in bottles of 100 (NDC-0187- 3750-10), with Becalm (Becalm) 5 imprinted on the opaque green cap and ICN imprinted on the opaque yellow body.
10 mg hard gelatin capsules in bottles of 100 (NDC-0187- 3751-10), with Becalm (Becalm) 10 imprinted on the opaque black cap and ICN imprinted on the opaque green body.
25 mg hard gelatin capsules in bottles of 100 (NDC-0187- 3758-10), with Becalm (Becalm) 25 imprinted on the opaque green cap and ICN imprinted on the opaque white body.
Store at 25°C (77°F); excursions permitted to 15°C - 30°C (59°F - 86°F).
Vaieant Pharmaceuticals International Costa Mesa, CA 92626. Rev. July 2005. FDA rev date: 9/6/2002
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What other drugs will affect Becalm?
When this drug applied simultaneously with:
- antipsychotic drugs (neuroleptics), antidepressants, sedatives, hypnotics, anesthetics, analgesics, ethanol enhanced the inhibitory effect on central nervous system, especially when administered parenterally.
- concomitant use of antacids can delay but not reduce the absorption of Becalm.
- hormonal contraceptives increases the effectiveness of Becalm.
- with muscle relaxants may enhance the action of muscle relaxants, with levodopa - may suppress antiparkinsonian action.
- theophylline at low doses perverts sedative effect of Becalm.
- phenobarbital and phenytoin may accelerate the metabolism of Becalm. In rare cases this medication inhibits the metabolism and enhances the action of phenytoin.
- may increase the toxicity of cyclophosphamide.
- cimetidine, omeprazole, disulfiram may increase the intensity and duration of action of this medicine.
