Cyclopam Injections Uses

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How do you administer this medicine?
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What is Cyclopam Injections?

Cyclopam Injections relieves spasms of the muscles in the stomach and intestines.

Cyclopam Injections is used to treat functional bowel or irritable bowel syndrome.

Cyclopam Injections may also be used for purposes not listed in this medication guide.

Cyclopam Injections indications

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Cyclopam Injections® (Cyclopam Injections hydrochloride) is indicated for the treatment of patients with functional bowel/irritable bowel syndrome.

How should I use Cyclopam Injections?

Use Cyclopam Injections 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 Cyclopam Injections.

Uses of Cyclopam Injections in details

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Cyclopam Injections 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).

Cyclopam Injections 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]

Cyclopam Injections 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

Cyclopam Injections

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

Storage And Handling

Cyclopam Injections Capsules

10 mg blue capsules, imprinted Cyclopam Injections 10, supplied in bottles of 100. Store at room temperature, preferably below 86°F (30°C).

NDC number: 58914-012-10.

Cyclopam Injections Tablets

20 mg compressed, light blue, round tablets, debossed Cyclopam Injections 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.

Cyclopam Injections 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

Cyclopam Injections interactions

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What other drugs will affect Cyclopam Injections?

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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 Cyclopam Injections 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 Cyclopam Injections: 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 Cyclopam Injections, 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.

Cyclopam Injections side effects

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What are the possible side effects of Cyclopam Injections?

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The pattern of adverse effects seen with Cyclopam Injections 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 Cyclopam Injections 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 Cyclopam Injections 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 Cyclopam Injections 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 Cyclopam Injections 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 Cyclopam Injections. 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.

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 Cyclopam Injections.

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 Cyclopam Injections.

Cyclopam Injections contraindications

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What is the most important information I should know about Cyclopam Injections?

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 Cyclopam Injections.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Cyclopam Injections can decrease your sweating, which can lead to heat stroke in a hot environment.

Stop using Cyclopam Injections 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 Cyclopam Injections. 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 Cyclopam Injections:

Dicyclomine


Unit description / dosage (Manufacturer)Price, USD
Injectable; Injection; Dicyclomine Hydrochloride

List of Cyclopam Injections substitutes (brand and generic names):

Cyclominol 20mg Tablet (Noel Pharmaceuticals)$ 0.01
DECOLIC INJ. Injection / 10mg per ml / 2ml units (KonTest Chemicals)$ 0.09
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
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)
Dicyclomine / K.S. 10 mg/1 mL x 2 mL (Claris)

References

  1. PubChem. "dicyclomine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "dicyclomine". http://www.drugbank.ca/drugs/DB00804 (accessed September 17, 2018).
  3. 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 Cyclopam Injections 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 Cyclopam Injections. 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

1 consumer reported useful

Was the Cyclopam Injections drug useful in terms of decreasing the symptom or the disease?
According to the reports released by ndrugs.com website users, the below mentioned percentages of users say the drug is useful / not useful to them in decreasing their symptoms/disease. The usefulness of the drug depends on many factors, like severity of the disease, perception of symptom, or disease by the patient, brand name used [matters only to a certain extent], other associated conditions of the patient. If the drug is not effective or useful in your case, you need to meet the doctor to get re-evaluated about your symptoms/disease, and he will prescribe an alternative drug.
Users%
Not useful1
100.0%


1 consumer reported price estimates

Was the price you paid to purchase the drug reasonable? Did you feel it was expensive?
The below mentioned numbers have been reported by ndrugs.com website users about whether the Cyclopam Injections drug is expensive or inexpensive. There is a mixed opinion among users. The rating about the cost of the drug depends on factors like which brand drug the patient purchased, how effective it was for the price paid, the country or place the drug is marketed, and the economic condition of the patient. The users who feel the drug is expensive can look for an alternative brand drug or a generic drug to save the cost.
Users%
Expensive1
100.0%


Consumer reported time for results

No survey data has been collected yet


5 consumers reported age

Users%
1-51
20.0%
16-291
20.0%
6-151
20.0%
> 601
20.0%
46-601
20.0%


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Information checked by Dr. Sachin Kumar, MD Pharmacology

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