What is Cyclominol?
Cyclominol relieves spasms of the muscles in the stomach and intestines.
Cyclominol is used to treat functional bowel or irritable bowel syndrome.
Cyclominol may also be used for purposes not listed in this medication guide.
Cyclominol indications
Cyclominol® (Cyclominol hydrochloride) is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.
How should I use Cyclominol?
Use Cyclominol as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- Cyclominol is usually given as an injection at your doctors office, hospital, or clinic. If you will be using Cyclominol at home, a health care provider will teach you how to use it. Be sure you understand how to use Cyclominol. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.
- Cyclominol is for intramuscular (IM) injection only. It is NOT for intravenous (IV) use.
- Do not use Cyclominol if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
- Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.
- The injection form of Cyclominol is only given short-term when the oral form cannot be taken. Your health care provider will prescribe the oral form of Cyclominol as soon as you are able to take it.
- Use Cyclominol on a regular schedule around the clock, unless your doctor tells you otherwise.
- If you miss a dose of Cyclominol, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Cyclominol.
Uses of Cyclominol in details
Cyclominol is used to treat periodic spasms and pain in abdomen and stomach, intestinal cramps, irritable bowel syndrome (disorder of the intestines that leads to cramps in the abdomen, gas, bloating and changes in bowel habits) and inability to control urine (urinary incontinence).
Cyclominol description
A muscarinic antagonist used as an antispasmodic and in urinary incontinence. It has little effect on glandular secretion or the cardiovascular system. It does have some local anesthetic properties and is used in gastrointestinal, biliary, and urinary tract spasms. [PubChem]
Cyclominol dosage
Dosage must be adjusted to individual patients needs.
Oral Dosage And Administration In Adults
The recommended initial dose is 20 mg four times a day. After one week treatment with the initial dose, the dose may be increased to 40 mg four times a day unless side effects limit dosage escalation. If efficacy is not achieved within 2 weeks or side effects require doses below 80 mg per day, the drug should be discontinued. Documented safety data are not available for doses above 80 mg daily for periods longer than 2 weeks.
Intramuscular Dosage And Administration In Adults
Cyclominol
Intramuscular Injection must be administered via
intramuscular route only. Do not administer by an other route. The recommended intramuscular dose is 10 mg to 20 mg four times a day.The intramuscular injection is to be used only for 1 or 2 days when the patient cannot take oral medication.
Intramuscular injection is about twice as bioavailable as oral dosage forms.
Preparation For
Intramuscular Administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Aspirate the syringe before injecting to avoid intravascular injection, since thrombosis may occur if the drug is inadvertently injected intravascularly.
How supplied
Dosage Forms And Strengths
- Cyclominol 10 mg capsules: blue, imprinted Cyclominol 10
- Cyclominol 20 mg tablets: compressed, light blue, round, debossed Cyclominol 20
- Cyclominol injection 20 mg/2 mL (10 mg/mL)
Storage And Handling
Cyclominol Capsules
10 mg blue capsules, imprinted Cyclominol 10, supplied in bottles of 100. Store at room temperature, preferably below 86°F (30°C).
NDC number: 58914-012-10.
Cyclominol Tablets
20 mg compressed, light blue, round tablets, debossed Cyclominol 20, supplied in bottles of 100. To prevent fading, avoid exposure to direct sunlight. Store at room temperature, preferably below 86°F (30°C).
NDC 58914-013-10.
Cyclominol Injection
20 mg/2 mL (10 mg/mL) injection supplied in boxes of five 20 mg/2 mL ampules (10 mg/mL). Store at room temperature, preferably below 86°F (30°C). Protect from freezing.
NDC 58914-080-52.
Manufactured for: Aptalis Pharma US, Inc. 100 Somerset Corporate Boulevard, Bridgewater, NJ 08807 USA. Revised: June 2013
Cyclominol interactions
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What other drugs will affect Cyclominol?
Antiglaucoma Agents
Anticholinergics antagonize the effects of antiglaucoma agents. Anticholinergic drugs in the presence of increased intraocular pressure may be hazardous when taken concurrently with agents such as corticosteroids. Use of Cyclominol in patients with glaucoma is not recommended.
Other Drugs With Anticholinergic Activity
The following agents may increase certain actions or side effects of anticholinergic drugs including Cyclominol: amantadine, antiarrhythmic agents of Class I (e.g., quinidine), antihistamines, antipsychotic agents (e.g., phenothiazines), benzodiazepines, MAO inhibitors, narcotic analgesics (e.g., meperidine), nitrates and nitrites, sympathomimetic agents, tricyclic antidepressants, and other drugs having anticholinergic activity.
Other Gastrointestinal Motility Drugs
Interaction with other gastrointestinal motility drugs may antagonize the effects of drugs that alter gastrointestinal motility, such as metoclopramide.
Effect Of Antacids
Because antacids may interfere with the absorption of anticholinergic agents including Cyclominol, simultaneous use of these drugs should be avoided.
Effect On Absorption Of Other Drugs
Anticholinergic agents may affect gastrointestinal absorption of various drugs by affecting gastrointestinal motility, such as slowly dissolving dosage forms of digoxin; increased serum digoxin concentration may result.
Effect On Gastric Acid Secretion
The inhibiting effects of anticholinergic drugs on gastric hydrochloric acid secretion are antagonized by agents used to treat achlorhydria and those used to test gastric secretion.
Cyclominol side effects
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What are the possible side effects of Cyclominol?
The pattern of adverse effects seen with Cyclominol is mostly related to its pharmacological actions at muscarinic receptors. They are a consequence of the inhibitory effect on muscarinic receptors within the autonomic nervous system. These effects are dose-related and are usually reversible when treatment is discontinued.
The most serious adverse reactions reported with Cyclominol hydrochloride include cardiovascular and central nervous system symptoms.
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure in controlled clinical trials involving over 100 patients treated for functional bowel/irritable bowel syndrome with Cyclominol hydrochloride at initial doses of 160 mg daily (40 mg four times a day)
In these trials most of the side effects were typically anticholinergic in nature and were reported by 61% of the patients. Table 1 presents adverse reactions (MedDRA 13.0 preferred terms) by decreasing order of frequency in a side-by-side comparison with placebo.
Table 1: Adverse reactions experienced in controlled clinical trials with decreasing order of frequency
| MedDRA Preferred Term | Cyclominol Hydrochloride (40 mg four times a day) % | Placebo % |
| Dry Mouth | 33 | 5 |
| Dizziness | 40 | 5 |
| Vision blurred | 27 | 2 |
| Nausea | 14 | 6 |
| Somnolence | 9 | 1 |
| Asthenia | 7 | 1 |
| Nervousness | 6 | 2 |
Nine percent (9%) of patients were discontinued from Cyclominol because of one or more of these side effects (compared with 2% in the placebo group). In 41% of the patients with side effects, side effects disappeared or were tolerated at the 160 mg daily dose without reduction. A dose reduction from 160 mg daily to an average daily dose of 90 mg was required in 46% of the patients with side effects who then continued to experience a favorable clinical response; their side effects either disappeared or were tolerated.
Postmarketing Experience
The following adverse reactions, presented by system organ class in alphabetical order, have been identified during post approval use of Cyclominol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Cardiac disorders: palpitations, tachyarrhythmias
- Eye disorders: cycloplegia, mydriasis, vision blurred
- Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, dry mouth, dyspepsia, nausea, vomiting
- General disorders and administration site conditions: fatigue, malaise
- Immune System Disorders: drug hypersensitivity including face edema, angioedema, anaphylactic shock
- Nervous system disorders: dizziness, headache, somnolence, syncope
- Psychiatric disorders: As with the other anti-cholinergic drugs, cases of delirium or symptoms of delirium such as amnesia (or transient global amnesia), agitation, confusional state, delusion, disorientation, hallucination (including visual hallucination) as well as mania, mood altered and pseudodementia, have been reported with the use of Cyclominol. Nervousness and insomnia have also been reported.
- Reproductive system and breast disorders: suppressed lactation
- Respiratory, thoracic and mediastinal disorders: dyspnoea, nasal congestion
- Skin and subcutaneous tissue disorder: dermatitis allergic, erythema, rash
Cases of thrombosis, thrombophlebitis and injection site reactions such as local pain, edema, skin color change and even reflex sympathetic dystrophy syndrome have been reported following inadverent IV injection of Cyclominol.
Adverse Reactions Reported with Similar Drugs with Anticholinergic/Antispasmodic Action
Gastrointestinal: anorexia,
Central Nervous System: tingling, numbness, dyskinesia, speech disturbance, insomnia
Peripheral Nervous System: With overdosage, a curare-like action may occur (i.e., neuromuscular blockade leading to muscular weakness and possible paralysis).
Ophthalmologic: diplopia, increased ocular tension
Dermatologic/Allergic: urticaria, itching, and other dermal manifestations;
Genitourinary: urinary hesitancy, urinary retention in patients with prostatic hypertrophy
Cardiovascular: hypertension
Respiratory: apnea
Other: decreased sweating, sneezing, throat congestion, impotence. With the injectable form, there may be temporary sensation of light-headedness. Some local irritation and focal coagulation necrosis may occur following the intramuscular injection of Cyclominol.
Cyclominol contraindications
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What is the most important information I should know about Cyclominol?
This medication may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Drinking alcohol can increase certain side effects of Cyclominol.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Cyclominol can decrease your sweating, which can lead to heat stroke in a hot environment.
Stop using Cyclominol and call your doctor right away if you have serious side effects such as confusion, hallucinations, unusual thoughts or behavior, fast or uneven heart rate, or if you urinate less than usual or not at all.
There are many other medicines that can interact with Cyclominol. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.
Active ingredient matches for Cyclominol:
Dicyclomine in India.
Dicycloverine hydrochloride in India.
| Unit description / dosage (Manufacturer) | Price, USD |
| Cyclominol 20 mg Tablet | $ 0.00 |
| CYCLOMINOL 20MG TABLET 1 strip / 10 tablets each (Noel Pharma India Pvt Ltd) | $ 0.08 |
| Cyclominol 20mg Tablet (Noel Pharma India Pvt Ltd) | $ 0.01 |
List of Cyclominol substitutes (brand and generic names): | |
| Ciclan (Venezuela) | |
| Cyclopam Injections | |
| Injectable; Injection; Dicyclomine Hydrochloride | |
| DECOLIC INJ. | |
| DECOLIC INJ. Injection / 10mg per ml / 2ml units (KonTest Chemicals) | $ 0.09 |
| DELCOLIC | |
| DELCOLIC 10 MG INJECTION 1 vial / 2 ML injection each (Kontest Chemicals Ltd) | $ 0.12 |
| DELCOLIC 40 MG TABLET 1 strip / 10 tablets each (Kontest Chemicals Ltd) | $ 0.32 |
| DELCOLIC 80 MG TABLET 1 strip / 10 tablets each (Kontest Chemicals Ltd) | $ 0.60 |
| Delcolic 40mg Tablet (Kontest Chemicals Ltd) | $ 0.03 |
| Delcolic 80mg Tablet (Kontest Chemicals Ltd) | $ 0.06 |
| Di-Spaz | |
| Di-Syntramine | |
| Dibent | |
| Diciclor (Venezuela) | |
| Dicicloverina [Inn-Spanish] | |
| Dicigon (Mexico) | |
| Dicyclocot | |
| Dicyclomine | |
| Capsule; Oral; Dicyclomine Hydrochloride 10 mg (Claris) | |
| Tablet; Oral; Dicyclomine Hydrochloride 20 mg (Claris) | |
| Syrup; Oral; Dicyclomine Hydrochloride 10 mg / 5 ml (Claris) | |
| Injectable; Injection; Dicyclomine Hydrochloride 10 mg / ml (Claris) | |
| Bentyl 10 mg/ml ampul (Claris) | $ 12.28 |
| Dicyclomine 10 mg/ml vial (Claris) | $ 8.58 |
| Dicyclomine Hydrochloride 10 mg/ml (Claris) | $ 3.41 |
| Dicyclomine hcl powder (Claris) | $ 1.00 |
| Bentyl 10 mg capsule (Claris) | $ 0.79 |
| Bentyl 20 mg tablet (Claris) | $ 0.75 |
| Dicyclomine HCl 10 mg capsule (Claris) | $ 0.47 |
| Dicyclomine HCl 20 mg tablet (Claris) | $ 0.40 |
| Dicyclomine 20 mg tablet (Claris) | $ 0.31 |
| Bentylol 20 mg Tablet (Claris) | $ 0.23 |
| Bentyl 10 mg/5ml Syrup (Claris) | $ 0.15 |
| Bentylol 10 mg Tablet (Claris) | $ 0.12 |
| Dicyclomine HCl 10 mg/5ml Solution (Claris) | $ 0.10 |
| Bentylol 2 mg/ml Syrup (Claris) | $ 0.06 |
| DICYCLOMINE Injection / 20mg / 2ml units (Claris) | $ 0.03 |
| Dicyclomine 20mg INJ / 2ml (Claris) | $ 0.03 |
| Dicyclomine / Y.Y. 10 mg x 1000's (Claris) | |
| Dicyclomine / Y.Y. 10 mg/1 mL x 2 mL (Claris) | |
| 20 mg x 2ml (Claris) | $ 0.03 |
| Dicyclomine / Sinton 10 mg/1 mL x 2 mL (Claris) | |
| 100 tablet in 1 bottle, plastic (Claris) | |
| 100 tablet in 1 box, unit-dose (Claris) | |
| 1000 tablet in 1 bottle, plastic (Claris) | |
See 167 substitutes for Cyclominol | |
References
- PubChem. "dicyclomine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "dicyclomine". http://www.drugbank.ca/drugs/DB00804 (accessed September 17, 2018).
- DTP/NCI. "Merbentyl: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Cyclominol are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Cyclominol. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported useful
No survey data has been collected yetConsumer reported price estimates
No survey data has been collected yetConsumer reported time for results
No survey data has been collected yetConsumer reported age
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Information checked by Dr. Sachin Kumar, MD Pharmacology
