Chlordiazepoxide/Mebeverine

Chlordiazepoxide (chlordiazepoxide) 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 Chlordiazepoxide (chlordiazepoxide) 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.

Irritable bowel syndrome & allied conditions eg, chronic irritable colon, spastic constipation, mucous colitis and spastic colitis. Symptomatic treatment of abdominal pain, cramps, nonspecific diarrhoea & flatulence. GI spasm secondary to organic diseases eg, diverticulitis, gastritis, duodenitis, oesophagitis, cholecystitis, Crohn's disease, ulcerative colitis, peptic ulcer, gallbladder disease, hiatus hernia, GIT inflammation.

Chlordiazepoxide is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Chlordiazepoxide affects chemicals in the brain that may become unbalanced and cause anxiety.

Chlordiazepoxide is used to treat anxiety disorders or alcohol withdrawal.

Chlordiazepoxide may also be used for other purposes not listed in this medication guide.

Because of the wide range of clinical indications for Chlordiazepoxide (chlordiazepoxide), the optimum dosage varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects.

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.

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 Chlordiazepoxide (chlordiazepoxide HCI).

How supplied

Chlordiazepoxide (chlordiazepoxide HCI) Capsules are available in the following presentations:

5 mg hard gelatin capsules in bottles of 100 (NDC-0187- 3750-10), with Chlordiazepoxide (chlordiazepoxide) 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 Chlordiazepoxide (chlordiazepoxide) 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 Chlordiazepoxide (chlordiazepoxide) 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

Adults: 1 capsule twice daily (1 in the morning and 1 in the evening).

Special Populations: Elderly, Renal and Hepatic Impairment: No posology studies in elderly, renal and/or hepatically impaired patients have been performed. However, no specific risk for elderly, renal and/or hepatically impaired patients could be identified from available post-marketing data. No dosage adjustment is deemed necessary in these patients.

Missed Dose: In case of ≥1 doses missed, continue with the next dose as prescribed; the missed doses are not to be taken in addition to the regular dose.

Administration: The capsules should be swallowed with a sufficient amount of water (at least 100 mL of water).

It should not be chewed because the coating is intended to ensure a prolonged release mechanism.

See also:
What is the most important information I should know about Chlordiazepoxide?

Do not use this medication if you are allergic to chlordiazepoxide or to other benzodiazepines, such as alprazolam (Xanax), clorazepate (Tranxene), diazepam (Valium), lorazepam (Ativan), or oxazepam (Serax).

This medication can cause birth defects in an unborn baby. Do not use chlordiazepoxide if you are pregnant.

Before taking chlordiazepoxide, 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 chlordiazepoxide. 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 chlordiazepoxide.

Chlordiazepoxide may be habit-forming and should be used only by the person it was prescribed for. Chlordiazepoxide 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.

Hypersensitivity to mebeverine HCl or to any of the excipients of Mebeverine.

Use Chlordiazepoxide as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Chlordiazepoxide is usually administered as an injection at your doctor's office, hospital, or clinic.
• If you are using Chlordiazepoxide at home, carefully follow the injection procedures taught to you by your health care provider.
• If the medicine contains particles or is discolored, or if the vial/container is cracked or damaged in any way, do not use it.
• Try to stay in bed for 3 hours after taking Chlordiazepoxide.
• Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor, nurse, or pharmacist to explain local regulations for selecting an appropriate container and properly disposing of the container when full.
• If you miss a dose of Chlordiazepoxide and you are using it regularly, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your health care provider. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Chlordiazepoxide.

Chlordiazepoxide 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 Chlordiazepoxide

Take 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.

Mebeverine is used to treat irritable bowel syndrome (disorder of the intestines that leads to cramps in the abdomen, gas, bloating and changes in bowel habits). It is also used to treat other conditions that involve spasm and pain related to small and large bowel.

See also:
What other drugs will affect Chlordiazepoxide?

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 chlordiazepoxide.

- hormonal contraceptives increases the effectiveness of chlordiazepoxide.

- with muscle relaxants may enhance the action of muscle relaxants, with levodopa - may suppress antiparkinsonian action.

- theophylline at low doses perverts sedative effect of Chlordiazepoxide.

- phenobarbital and phenytoin may accelerate the metabolism of chlordiazepoxide. 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.

No interaction studies have been performed except with alcohol. In vitro and in vivo studies in animals have demonstrated the absence of any interaction between Mebeverine and ethanol.

Incompatibilities: Not applicable.

See also:
What are the possible side effects of Chlordiazepoxide?

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 Chlordiazepoxide (chlordiazepoxide) treatment.

Blood dyscrasias (including agranulocytosis), jaundice and hepatic dysfunction have occasionally been reported during therapy. When Chlordiazepoxide (chlordiazepoxide) treatment is protracted, periodic blood counts and liver function tests are advisable.

DRUG ABUSE AND DEPENDENCE: Chlordiazepoxide 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 chlordiazepoxide. 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 chlordiazepoxide or, other, psychotropic agents because of the predisposition of such patients to habituation and dependence.

Although adverse effects appear rare, gastrointestinal disturbances, dizziness, headache, insomnia, anorexia and tachycardia have been reported in patients receiving Mebeverine.

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. Chlordiazepoxide 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) Chlordiazepoxide is a controlled substance in the U.S.

Each capsule contains mebeverine HCl 200 mg.

Mebeverine also contains the following excipients: Capsule Content (Granules): Magnesium stearate, polyacrylate dispersion 30%, talc, hypromellose, methacrylic acid-ethyl acrylate copolymer (1:1) dispersion 30% and glycerol triacetate. Capsule Shell: Gelatin, titanium dioxide (E171). Printing Ink: Shellac (E904), black iron oxide (E172), propylene glycol, concentrated ammonia solution, potassium hydroxide.