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Motilium (Domperidone)

Brand name: Motilium

Generic Name : Domperidone

Manufacturer : Janssen-Cilag

Medicine Category : Miscellaneous : Antiemetics & Antivertigo Drugs

FDA Pregnant Category : Not established

What is it used for?

- Nausea and vomiting in adults and children
- Relief of upper abdominal discomfort, sense of fullness and regurgitaion of stomach contents in adults

How does it work?

This medicine contains the active ingredient domperidone, which is a type of medicine called a dopamine antagonist. It is an anti-emetic medicine, meaning it is used to treat nausea and vomiting. It can also be used to treat abdominal bloating, fullness and discomfort in adults.

Domperidone works primarily by blocking dopamine receptors found in an area of the brain known as the chemoreceptor trigger zone (CTZ). The CTZ is activated by nerve messages from the stomach when an irritant is present. It is also activated directly by agents circulating in the blood, for example anti-cancer medicines. Once activated, it sends messages to another area of the brain, the vomiting centre, which in turn sends messages to the gut, causing the vomiting reflex.

Blocking the dopamine receptors in the CTZ prevents nausea messages from being sent to the vomiting centre. This reduces the sensation of nausea and prevents vomiting.

Domperidone also blocks dopamine receptors found in the upper end of the digestive system. This results in tightening of the muscles at the entry to the stomach, relaxation of the muscles at the exit of the stomach and increased contraction of the muscles in the stomach itself. These actions speed the passage of food through the stomach into the intestine, which physically helps to prevent vomiting.

Both actions make domperidone useful in treating nausea and vomiting due to many causes, including anti-cancer chemotherapy, emergency hormonal contraception and in migraine. Domperidone is also used to prevent nausea and vomiting that can be caused by medicines for Parkinson's disease, such as levodopa, bromocriptine and apomorphine.

Due to its stimulating action on the gut, which speeds up stomach emptying into the intestine, domperidone can also be used to relieve upper abdominal discomfort, a sense of fullness or bloating, and regurgitation of the stomach contents that some people experience following meals. Domperidone can be bought over-the-counter from pharmacies for this purpose as the branded product Motilium 10. It should only be used for these purposes in adults.

Actions :

Peripheral dopamine antagonist.

Pharmacology: Motilium: Motilium's mechanism of action is based on a marked dopamine-blocking activity. Due to its weak penetration across the hematoencephalic barrier, Motilium has almost no effect on the dopaminergic receptors in the brain, therefore excluding any psychotropic or neurologic effect.

In vitro and in vivo pharmacologic studies in man and animals have shown the following:

Motilium not only relieves experimental inhibition of gastric motility (eg, that provoked by the dopaminomimetic apomorphine) but it also quickens postprandial gastric evacuation which is not artificially slowed down.

Motilium increases the tonicity of the cardial sphincter and augments the dilation amplitude of the postprandial motility of the pyloric sphincter.

Motilium does not influence gastric secretion.

Motilium-M: The mechanism of action of Motilium-M is probably based on its antidopamine activity. Motilium-M has virtually no effect on the dopaminergic receptors of the brain so that psychotropic or neurologic effect are practically absent. Motilium-M is well absorbed and rapidly metabolised.

On the intact stomach preparation of the guinea pig, dopamine induces pronounced relaxations. These relaxations could be antagonized by both domperidone base (ED50 = 1.9 x 106 H) and domperidone maleate (ED50 = 1.8 x 106 H). There was no difference in potency observed between the base and maleate salt of domperidone.

Pharmacokinetics: Motilium: Motilium is absorbed and rapidly metabolized.

Absorption and Distribution: Peak plasma concentrations are attained at 10-30 min after oral administration, and at 1-2 hrs after rectal administration of suppositories.

Distribution data in rats with radiolabelled drug have shown wide distribution in body tissues except the CNS, where only low concentrations occur. Tissue concentrations after oral Motilium were higher than the corresponding plasma concentration, except in the brain and reproductive organs.

Excretion: Motilium undergoes rapid and extensive biotransformation by hydroxylation and oxidative N-dealkylation. The proportion of the drug remaining unchanged is small, accounting for only 1.4% of the total urinary radioactivity and 10% of the faecal radioactivity. After oral administration of 409 mg 14C-domperidone in healthy volunteers, 31% of the radioactivity is excreted in the urine and 60% in the faeces over a period of 4 days (Meuldermans et al, 1981). Practically all of the urinary radioactivity is recovered within the first 24 hrs, with only 1.4% (0.43% of the dose) present as unchanged drug. The greatest proportion of that part of the dose recovered in the urine is in the form of glucuronide conjugates of the metabolite formed by oxidative N-dealkylation. The elimination half-life of Motilium is 7.5 hrs in healthy subjects (Heykants et al, 1981b), and is prolonged to up to 20.8 hrs in patients with severe renal dysfunction (data on file, Janssen). However, since renal clearance is small compared with total plasma clearance (700 mL/min), accumulation should not occur in renal dysfunction.

The Place of Motilium in Therapy: Motilium has been shown to control the cluster of symptoms commonly referred to as postprandial dyspepsia and to be an effective antiemetic in adults and children with nausea and vomiting due to a variety of causes.

Motilium-M: The bioavailability of domperidone was studied in healthy male volunteers in the normal fasted state and when pre-treated with cimetidine and sodium bicarbonate (to reduce gastric acidity). Two dosage forms were compared: Domperidone base (R 33 812) in film-coated tablets and domperidone maleate (R 50 121). In the normal fasted state, the bioavailability of domperidone was similar for both dosage forms. Reduced gastric acidity lowered the bioavailability of the drug in some subjects when domperidone base was administered, but it did not influence the absorption from its maleate salt.

How should Motilium (Domperidone) be used?

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Motilium the following should be considered:
Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to domperidone.
Pregnancy—Pregnancy—domperidone has not been studied in pregnant women. However, domperidone has not been shown to cause birth defects or other problems in animal studies.

Breast-feeding— Breast-feeding—Domperidone passes into the breast milk, but it is not known if domperidone will cause unwanted effects in the newborn. It may be necessary for you to take another medicine or to stop breast-feeding during treatment. Be sure you have discussed the risks and benefits of the medicine with your doctor.

Children—Children—Studies on Motilium have been done only in adult patients, and there is no specific information comparing use of domperidone in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing the use of domperidone in the elderly with use in other age groups.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your doctor or pharmacist if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine, especially:

Monoamine oxidase (MAO) inhibitors (furazolidone [e.g., Furoxone], phenelzine [e.g., Nardil], procarbazine [e.g., Matulane], selegilene [e.g., Eldepryl], tranylcypromine [e.g., Parnate])

Warning

- This medicine is not recommended for long term use.
- Motilium tablets contain lactose and may be unsuitable for people with lactose intolerance, glucose/galactose malabsorption or a genetic disorder leading to accumulation of galactose in the blood (galactosaemia). Motilium suspension contains sorbitol and may be unsuitable for people with sorbitol intolerance.

Use with caution in

- Decreased liver function
- Infants and young children
- Prolonged repeated use in severely decreased kidney function

Not to be used in

- Abnormal hole in the stomach or intestines (gastrointestinal perforation)
- Bleeding from the gut (gastrointestinal haemorrhage)
- Cancer of the pituitary gland resulting in over-production of the hormone prolactin (prolactinoma)
- Conditions in which stimulating movement through the stomach could be harmful (your doctor will know)
- Obstruction of the stomach or intestines

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy.

If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby.Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

- The safety of this medicine for use during pregnancy has not been established. It is not recommended for use in pregnancy unless considered essential by your doctor. Seek medical advice from your doctor.
- This medicine passes into breast milk in small amounts. Seek medical advice from your doctor before breastfeeding.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

- Diarrhoea
- Abnormal enlargement of breasts in men (gynaecomastia)
- Abnormal movements of the hands, legs, face, neck and tongue, eg tremor, twitching, rigidity (extrapyramidal effects)
- Breast pain
- High blood prolactin (milk producing hormone) level (hyperprolactinaemia). Sometimes this can lead to symptoms such as breast enlargement, production of milk and stopping of menstrual periods.
- Stomach cramps
- Decreased sex drive
- Itchy rash (urticaria)

The side effects listed above may not include all of the side effects reported by the drug's manufacturer.

For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

How can this medicine affect other medicines?

Domperidone may increase the speed of absorption of certain medicines from the gut, for example paracetamol.

Recommended dosage

Motilium: Chronic Dyspepsia: Preferably oral administration.

Adults: 10-20 mg 3-4 times a day, 15-30 min before meals. If necessary, this dose can again be taken before retiring.

Children: 0.1% oral solution: ¼ measuring spoon (to the 1.25-mL mark)/5 kg body weight 3 times a day before meals (and if necessary, before retiring).

Remarks: If required, the dosage mentioned can be doubled.

Acute and Subacute Conditions (mainly nausea, vomiting, hiccups): Adults: Oral Route: 20 mg (5 tsp of oral suspension 3-4 times a day, before meals and before retiring (this dose can be doubled).
Children: Oral Route: 0.1% oral solution: ¼ measuring spoon/5 kg body weight 3-4 times a day before meals.

Motilium-M: Chronic Dyspepsia (mainly oral administration): Adults: 10-20 mg 3-4 times daily, 15-30 min before meals and if necessary, once more before retiring.
When results are not satisfactory, the dosage may be doubled.

When antacids or antisecretory agents are used concomitantly, they can be taken together with Motilium-M.

Acute and Subacute Conditions (particularly nausea and vomiting): Adults: 20 mg (2 tabs) 3-4 times daily before meals and before bedtime (if necessary, this dosage may be doubled).

Overdosage

Symptoms

Symptoms of overdosage may include drowsiness, disorientation and extrapyramidal reactions, especially in children.

Treatment

Anticholinergics, anti-parkinsonian agents or antihistamines with anticholinergic properties may be helpful in controlling the extrapyramidal reactions. In the event of accidental overdosage supportive measures including gastric lavage with sodium bicarbonate, should be employed. There is no specific antidote. Close observation and supportive therapy are recommended. Symptoms are self-limiting and usually disappear within 24 hours.

Storage

Protect from light. Store at room temperature.

 

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