Cyclopam

Therapeutic Indications

Cyclopam is classified as an antispasmodic drug. It contains Paracetamol and Dicyclomine. The drug is used in the treatment, prevention, and management of several conditions that include:

• Stomach pain
• Pain during periods
• Cold
• Pain in joints
• Headaches
• Irritable bowel syndrome
• Fever
• Abdominal pain
• Relieves wind, bloating and discomfort
• Cramps
• Gastrointestinal spasms
• Toothaches
• Ear pain
• Flu
• Loss of urination control
• Peptic ulcer
• Arthralgia
• Motion sickness
• Catarrh
• Bowel spasms
• Nerve pain
• Sore throats

Do I need a prescription for cyclopam?

Cyclopam can be bought from pharmaceuticals and online drug stores. But, it is a prescription drug and you must get one from a registered medical practitioner.

Dosage

Cyclopam dosage depends on the patients’ response to the drug. The recommended dosage for the tablets are:

• Adults: 80 mg/ day that is divided into 4 doses. The tablets need to be taken 30-60 minutes before mealtime. The dose can be adjusted to 160 mg/ day still divided for 4 doses in cases of slow response.

• Children with infant colic: 5-10 mg in a day at an interval of 6-8 hours. The drug should be given at least 15 minutes before mealtime.

Chemical composition

The active ingredients of Cyclopam tablets include Paracetamol or Acetaminophen and Dicyclomine. Dicyclomine is also known as Dicycloverine. Each tablet has 500 mg of paracetamol and 20 mg of Dicyclomine.

Mechanism of Action (MOA)

Cyclopam improves the condition of the patient by causing an increase in the flow of blood closer to the surface of the skin, thus allowing heat loss to occur faster. It also increases the amount of sweating, thus more heat is lost during the process. This helps in increasing the pain threshold.

The anticholinergic agent Dicyclomine works by preventing the occurrence of sudden contractions in the smooth muscles. It is a derivative of carboxylic acid. It prevents acetylcholine binding to muscarinic receptors found on the smooth muscles This ensure the relaxation of muscles in the gastrointestinal tract, preventing propulsive motility in gastro intestine and reduces secretion of gastric acid. This allows the relieving of bloating, cramping and discomfort.

Paracetamol is an analgesic (non-opioid) also found in the class of anti-pyretic drugs. It functions by the blocking of a number of chemical messengers from being released (Prostaglandins). As a result, the impulse generation for pain is stopped. It also works by the regulating the working of the center for heat regulation and thus temperature being normalized.

Contraindications

Cyclopam should not be used for patients who have the following conditions. Inform your doctor if you have any of the following conditions:

• Glaucoma

• Hypersensitivity. Patients with allergic reaction to Dicyclomine should not use the drug. Signs of allergy include breathing difficulties, swallowing problems, and rashes, swelling occurring on the face, tongue, lips, and throat

• Myasthenia gravis

• Gastrointestinal tract obstructive disease

• Uropathy that is obstructive

• Ulcerative colitis that is severe

• Hepatic impairment. The drug is not advised for use with patients with disease of the liver. The doctor might adjust the dose for individuals who do not have severe liver damage

• Acute hemorrhage in patients with a cardiovascular status that is unstable

• Infants less than 6 months old

• Cyclopam should not be used together with alcohol as it increases the risk of liver damage to the patient

• The drug should not be used during pregnancy or by patients planning to get pregnant. It has been shown to have some effects on the animal fetus but there is limited information on human studies. Use in pregnancy depends on whether the benefits outweigh the risk.

• The use of Cyclopam during lactation is not recommended as there are few human studies that show whether the drug passes through milk and what its effects would be to the nursing baby.

• Cyclopam does not affect the ability to operate heavy machinery and to drive. But in the case that it causes effects that affect the ability to concentrate, then the patient is advised not to drive or operate machinery.

• Patients with kidney disease are also not advised to use Cyclopam. In the case of the doctor’s recommendations to use the drug, dose adjustment is usually done.

• Enlarged prostate

• Indigestion or suffering from heartburn that arises from a hiatus hernia.

• Thyroid and heart problems

Side effects

Cyclopam is well tolerated by most patients. Some patients taking Cyclopam may experience a number of side effects from the ingredients of the drug. The side effects are dependent on the initial reaction to the drug and the dose. Some of the side effects experienced are rare but serious while some are common and not serious.

In case of side effects, the patients should consult the doctor and especially if the side effects do not go away. In such cases, the doctor may prescribe a different drug that the patient will be more comfortable with or the doctor may adjust the dose.

Common side effects include:

• Drowsiness
• Feeling of sickness
• Dizziness
• Lightheadedness
• Nausea
• Facial features being swollen
• Lethargy
• Toxicity of the liver
• Dry mouth. The patient is advised to take in a lot of water throughout the day.
• Blurred vision
• Weakness
• Nervousness
• Sleepiness
• Diarrhea. In case a patient’s experiences diarrhea, they are advised to take plenty of water or any other fluids. They should also avoid taking fried foods and fatty foods.
• Strong smelling urine
• Less frequent urination
• Dark colored urine
• Rash
• Loss of appetite( Anorexia)
• Vomiting
• Constipation
• Pain or difficulty as one urinates
• Problems with the kidney or liver if the drug is taken for long periods
• Bloating
• Allergic reactions to the components lead to shortness of breath, itching, and occurrence of a rash.

Some side effects occur very rarely but are severe and require medical attention immediately. These include:

• Mood swings
• Increase in the rate of the heartbeat
• Loss of coordination and speech that is slurred
• Steven-Johnson syndrome

If you accidentally take an overdose, call your doctor and report or rush into the emergency department of the nearest hospital and carry with you the drug package or label for identification.

The following signs may occur due to an overdose, tightness in the chest, wheezing, itching, bad cough, skin turning blue or gray, the occurrence of seizures, swelling of the tongue, face throat and lips, passing out, loss of logical and clear thinking, being unable to pass urine and rashes.

Drug interactions

The doctor should be informed of any medications you are currently taking whether drugs that are prescribed or bought over the counter, in case of taking any vitamin supplements or herbal supplements. The drugs may affect the uptake of Cyclopam or lower its effectiveness in treating the condition and in some instances it may increase the chances of some side effects occurring or Cyclopam may affect the working of the other medications.

A number of medications and products interact with Cyclopam and are listed below:

• Antacids
• Amantadine
• Alcohol
• Antihistamines
• Corticosteroids
• Digoxin
• Jaxtapid mipomersen
• Ketoconazole
• Zidovudine (used for HIV infections and AIDS)
• Domperidone and metoclopramide which are used for nausea and vomiting
• Drugs for thinning the blood and for the prevention of clotting like Warfarin
• Drugs for high levels of cholesterol treatment like colestyramine
•  Tricyclic antidepressants like amitriptyline
• Tablets used for sleeping such as barbiturates
• Nitrates
• Nitrites
• Quinidine
• Monoamine oxidase inhibitors
• Sympathomimetic agents
• Busulfan
• Leflunomide
• Potassium chloride
• Potassium citrate
• Zonisamide
• Topiramate
• Prilocaine
• Lomitapide

What to Do If You Skip a Dose

In case you skip a dose is it should be taken immediately when you realize it. But if the time for the next dose is very close then the dose is not taken and the normal schedule of taking the drug continued.

If you frequently miss doses, you should set a reminder or have a family member to remind you when it is time to take the drug. If many doses are missed it will affect the effectiveness of the drug and thus you can consult your doctor to change the schedule or adjust the dosage to one that you can adhere to.

Precautions

Precautionary measures need to be taken with patients taking Cyclopam. Patients with the following conditions and diseases are not advised on using the drug:

• Allergic reactions to its active ingredients.
• In the cases that it causes drowsiness or blurring the vision, the patient should not operate heavy machinery or drive
• The drug should not be taken together with alcoholic drinks as it increases the chances of liver and kidney toxicity
• An overdose of the drug results in weakness of muscles or cause paralysis
• Tachyarrhythmia
• Neuropathy that is autonomic
• Coronary heart disease
• Renal or hepatic diseases
• A hiatal hernia
• Expecting or those planning to be pregnant
• Lactating Mothers
• Patients taking anti-fungal drugs should take then at least 2 hours before taking Cyclopam
• Diarrhea
• Nerve disease and enlarged prostate
• Ulcers or inflammations that are chronic
• The medication should be kept at room temperature away from direct sunlight.
• The drug should be kept away from children and should not be given to children below the age of 6 months
• Do not take the drug is the expiry date has already been reached as it may cause poisoning
• In case the foil is tampered with or the drug is discolored.

Different Brands and Manufacturing Companies of cyclopam

Cyclopam is manufactured by the Indoco Remedies Ltd.

• Cyclopam Tablets( 10mg-250mg) –Mefenamic acid 250 mg and 10 mg Dicyclomine
• Cyclopam Tablets (20mg-500mg) – Paracetamol 500mg and 20 mg Dicyclomine
• Cyclopam Drops ( 10 Mg-40 Mg) – Dimethicone 40 mg and 10 mg Dicyclomine
• Cyclopam Suspension (10 mg-40 mg) –Dicyclomine 10 mg and 40 mg Simethicone
• Cyclopam Injections (10mg) – Dicyclomine 10 mg.

Substitutes of the drug

Other drugs that can be used as an alternative for Cyclopam that have the same strength include:

• Afdispas 20mg/500 mg Tablet – Anglo-French Drugs & Industries Ltd
• Biospas 20 mg/500mg Tablet – Biochem Pharmaceuticals Industries
• Baralgan Nu Tablet – Sanofi India Ltd
• Berberal 20 mg/500mg –Alembic Pharmaceuticals Ltd
• Cyclo P 20 mg/ 500mg Tablet – Laborate Pharmaceuticals India Ltd
• Colinol 20 mg/500 mg Tablet – Tenet Healthcare
• Cyclomec 29 mg/ 500mg Tablet – McW Healthcare
• Colimex 20 mg/500mg Tablet –Wallace Pharmaceuticals Pvt Ltd
• Colicspam 20 mg/500 mg Tablet – Leben Laboratories Pvt Ltd
• Lupispas Plus 20 mg/500mg Tablet-Lupin Ltd
• Dcmol 250 mg Tablet – Unison Pharmaceuticals Pvt Ltd
• Dolospas 20 mg/500 mg Tablet – Intas Pharmaceuticals Ltd
• Maxigan D 20 mg/500 mg Tablet – Unichem Laboratories Ltd
• Spasly 20 mg/500 mg Tablet – Cadila Pharmaceuticals Ltd
• Spasmo Corfen 20 Mg/500 Mg Tablet–Cornel Pharmaceuticals Pvt Ltd
• Spasmak 20 Mg/500 Mg Tablet–Makers Laboratories Ltd
• Spasgun 20 Mg/500 Mg Tablet–Wings Biotech Ltd
• Spasmak 20 Mg/500 Mg Tablet–Makers Laboratories Ltd
• Spasmak Y 20 Mg/500 Mg Tablet–Win-Medicare Pvt Ltd
• Swispas 20 mg/500 mg Tablet–Ind Swift Laboratories Ltd
• Spasmogil 20 Mg/500 Mg Tablet–Galpha Laboratories Ltd
• Spasmokem 20 Mg/500 Mg Tablet–Alkem Laboratories Ltd
• Spasmokem G 20 Mg/500 Mg Tablet–Alkem Laboratories Ltd
• Synospas Tablet – Syncom Formulations I Ltd
• Spasmorid 20 Mg/500 Mg Tablet–Cipla Ltd
• Trigan Tablet-Cadila Pharmaceuticals Ltd

References

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