chlordiazepoxide hydrochloride and clidinium bromide
Pharmaranks rates Chlordiazepoxide Hydrochloride and Clidinium Bromide 3.2/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Chlordiazepoxide Hydrochloride and Clidinium Bromide is a combination medicine containing Chlordiazepoxide Hydrochloride and Clidinium Bromide.
Generic · by Torrent
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Chlordiazepoxide Hydrochloride and Clidinium Bromide
- Form
- Capsule
- Strength
- Chlordiazepoxide Hydrochloride 5MG; Clidinium Bromide 2.5MG
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Torrent
- What the pharmacy pays
- ~$4.83 for 30 — not your price
- FDA application
- ANDA217385
- Availability
- Discontinued (per FDA)
- FDA boxed warning
- Yes — see the boxed warning
What is Chlordiazepoxide Hydrochloride and Clidinium Bromide?
From the FDA label:Chlordiazepoxide hydrochloride and clidinium bromide capsules USP, 5 mg/2.5 mg combines in a single capsule formulation the antianxiety action of chlordiazepoxide hydrochloride and the anticholinergic/spasmolytic effects of clidinium bromide. Each chlordiazepoxide hydrochloride and clidinium bromide capsules USP, 5 mg/2.5 mg contains the active ingredients 5 mg chlordiazepoxide hydrochloride and 2.5 mg clidinium bromide. Each capsule also contains the inactive ingredients corn starch, lactose monohydrate, talc, sodium lauryl sulfate, D&C Yellow No. 10, FD&C Green No. 3, titanium dioxide, and gelatin. The imprinting ink contains ammonia solution, black iron oxide, potassium hydroxide, propylene glycol, and shellac. Chlordiazepoxide hydrochloride is a versatile, therapeutic agent of proven value for the relief of anxiety and tension. It is indicated when anxiety, tension or apprehension are significant components of the clinical profile. It is among the safer of the effective psychopharmacologic compounds. Chlordiazepoxide hydrochloride is 7-chloro-2-(methylamino)-5-phenyl-3H-1,4-benzodiazepine 2-oxide monohydrochloride. A white to slightly yellow, crystalline powder, it is soluble in water. It is unstable in solution and the powder must be protected from light. The molecular weight is 336.2. The structural formula of chlordiazepoxide hydrochloride is as follows: Clidinium…
How to use
Because of the varied individual responses to tranquilizers and anticholinergics, the optimum dosage of chlordiazepoxide hydrochloride and clidinium bromide capsules varies with the diagnosis and response of the individual patient. The dosage, therefore, should be individualized for maximum beneficial effects. The usual maintenance dose is 1 or 2 capsules, 3 or 4 times a day administered before meals and at bedtime. Geriatric Dosing Dosage should be limited to the smallest effective amount to preclude the development of ataxia, oversedation or confusion. The initial dose should not exceed 2 chlordiazepoxide hydrochloride and clidinium bromide capsules per day, to be increased gradually as needed and tolerated.
Side effects
No side effects or manifestation not seen with either compound alone have been reported with the administration of chlordiazepoxide hydrochloride and clidinium bromide capsules. However, since the chlordiazepoxide hydrochloride and clidinium bromide capsules contain chlordiazepoxide hydrochloride and clidinium bromide, the possibility of untoward effects which may be seen with either of these two compounds cannot be excluded. When chlordiazepoxide hydrochloride has been used alone 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 with chlordiazepoxide hydrochloride 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 hydrochloride treatment. Blood dyscrasias,…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS and PRECAUTIONS ). Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients for signs and symptoms of respiratory depression and sedation.
Warnings
Important safety information
Concomitant use of benzodiazepines, including chlordiazepoxide hydrochloride and clidinium bromide capsules, and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Observational studies have demonstrated that concomitant use of opioid analgesics and benzodiazepines increases the risk of drug-related mortality compared to use of opioids alone. If a decision is made to prescribe chlordiazepoxide hydrochloride and clidinium bromide capsules concomitantly with opioids, prescribe the lowest effective dosages and minimum durations of concomitant use, and follow patients closely for signs and symptoms of respiratory depression and sedation. Advise both patients and caregivers about the risks of respiratory depression and sedation when chlordiazepoxide hydrochloride and clidinium bromide capsules is used with opioids (see PRECAUTIONS ) . As in the case of other preparations containing CNS-acting drugs, patients receiving chlordiazepoxide hydrochloride and clidinium bromide capsules should be cautioned about possible combined effects with opioids, alcohol and other CNS depressants. For the same reason, they should be cautioned against hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle. Usage In Pregnancy An increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam and meprobamate) during the first trimester of pregnancy has been suggested in several studies. Because use of these drugs is rarely a matter of urgency, their use during this period should almost always be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant during therapy or intend to become pregnant they should communicate with their physicians about the desirability of discontinuing the drug. As with all anticholinergic drugs, an inhibiting effect on lactation may occur (see ANIMAL PHARMACOLOGY ) .
Who should not take Chlordiazepoxide Hydrochloride and Clidinium Bromide
Chlordiazepoxide hydrochloride and clidinium bromide capsules are contraindicated in the presence of glaucoma (since the anticholinergic component may produce some degree of mydriasis) and in patients with prostatic hypertrophy and benign bladder neck obstruction. It is contraindicated in patients with known hypersensitivity to chlordiazepoxide hydrochloride and/or clidinium bromide.
Overdose — what happens if you take too much
Manifestations of chlordiazepoxide hydrochloride overdosage include somnolence, confusion, coma and diminished reflexes. Respiration, pulse and blood pressure should be monitored, as in all cases of drug overdosage, although, in general, these effects have been minimal following chlordiazepoxide hydrochloride overdosage. While the signs and symptoms of chlordiazepoxide hydrochloride and clidinium bromide capsules overdosage may be produced by either of its components, usually such symptoms will be overshadowed by the anticholinergic actions of clidinium bromide. The symptoms of overdosage of clidinium bromide are excessive dryness of mouth, blurring of vision, urinary hesitancy and constipation. General supportive measures should be employed, along with immediate gastric lavage. Administer physostigmine 0.5 to 2 mg at a rate of no more than 1 mg per minute. This may be repeated in 1 to 4 mg doses if arrhythmias, convulsions or deep coma recur. Intravenous fluids should be administered and an adequate airway maintained. Hypotension may be combated by the use of levarterenol or metaraminol. Methylphenidate or caffeine and sodium benzoate may be given to combat CNS-depressive effects. Dialysis is of limited value. Should excitation occur, barbiturates should not be used. As with the management of intentional overdosage with any drug, it should be borne in mind that multiple…
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
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Frequently asked questions
- How is Chlordiazepoxide Hydrochloride and Clidinium Bromide rated?
- pharmaranks gives Chlordiazepoxide Hydrochloride and Clidinium Bromide a composite score of 3.2 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Chlordiazepoxide Hydrochloride and Clidinium Bromide cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $4.83 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins. Pharmacies pay less for a same-class option, Mysoline — about $2.89 on the same basis.
- Is there a coupon or discount for Chlordiazepoxide Hydrochloride and Clidinium Bromide?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Chlordiazepoxide Hydrochloride and Clidinium Bromide. To pay less, Chlordiazepoxide Hydrochloride and Clidinium Bromide is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Chlordiazepoxide Hydrochloride and Clidinium Bromide?
- Chlordiazepoxide Hydrochloride and Clidinium Bromide is marketed by Torrent. You can see Torrent's full profile, rating, and other products on pharmaranks.
- Is Chlordiazepoxide Hydrochloride and Clidinium Bromide a brand-name or generic drug?
- Chlordiazepoxide Hydrochloride and Clidinium Bromide is a generic medication; its active ingredient is Chlordiazepoxide Hydrochloride and Clidinium Bromide. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Chlordiazepoxide Hydrochloride and Clidinium Bromide available over the counter?
- No. Chlordiazepoxide Hydrochloride and Clidinium Bromide is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Chlordiazepoxide Hydrochloride and Clidinium Bromide come in?
- Chlordiazepoxide Hydrochloride and Clidinium Bromide is currently marketed as capsule, per the FDA's National Drug Code Directory.
- Is Chlordiazepoxide Hydrochloride and Clidinium Bromide FDA-registered?
- Chlordiazepoxide Hydrochloride and Clidinium Bromide is on record with the U.S. FDA under application number ANDA217385. You can verify this on its official FDA label.
- Has Chlordiazepoxide Hydrochloride and Clidinium Bromide been recalled by the FDA?
- Chlordiazepoxide Hydrochloride and Clidinium Bromide has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Chlordiazepoxide Hydrochloride and Clidinium Bromide safe?
- There's no single safe-or-not verdict. pharmaranks gives Chlordiazepoxide Hydrochloride and Clidinium Bromide a recall-safety score of 64/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Chlordiazepoxide Hydrochloride and Clidinium Bromide?
- Chlordiazepoxide Hydrochloride and Clidinium Bromide's side effects are taken directly from its FDA label. From the label: No side effects or manifestation not seen with either compound alone have been reported with the administration of chlordiazepoxide hydrochloride and clidinium bromide capsules. However,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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chlordiazepoxide hydrochloride and clidinium bromide
64/100