Peristar is a medicine that increases the movements or contractions of the stomach and bowel. Peristar is also used to treat nausea and vomiting caused by other drugs used to treat Parkinson's Disease.
Peristar is to be given only by or under the immediate supervision of your doctor.
Peristar indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Dyspeptic symptom complex often associated with delayed gastric emptying, gastroesophageal reflux disease (GERD) or esophagitis: Epigastric sense of fullness, feeling of abdominal distention, upper abdominal pain, flatulence (gassiness), eructation (belching), and heartburn.
Short-term treatment of nausea and vomiting of various origins including functional, organic, infectious, diabetic origin, or induced by radiotherapy or medicine therapy. (It is not considered suitable for chronic nausea and vomiting, nor for the routine prophylaxis of postoperative vomiting.)
Treatment of nausea and vomiting induced by dopamine agonists ie, L-dopa and bromocriptine used in Parkinson's disease.
Peristar may also be given as needed, together with paracetamol for the symptomatic treatment of nausea and vomiting associated with migraine.
Uses of Peristar in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Peristar is used to treat vomiting or nausea caused due to indigestion, diseases or drugs. It is also used to relieve fullness of stomach, belching and heavy bloating, gas and heartburn for a longer period up to 2 weeks.
Peristar description
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Peristar is a synthetic anticoagulant and an indanedione derivative. It prevents the formation of active procoagulation factors II, VII, IX, and X, as well as the anticoagulant proteins C and S, in the liver by inhibiting the vitamin K mediated gamma-carboxylation of precursor proteins.
Peristar dosage
It is recommended to take oral Peristar before meals. If taken after meals, absorption of the drug is somewhat delayed.
Adults and Adolescents >12 years and weighing ≥35 kg:Tablets: One to two 10-mg tablet 3-4 times/day, with a maximum daily dose of 8 tablets (80 mg).
Oral Suspension:
10-20 mL (of oral susp containing Peristar 1 mg/mL) 3-4 times/day, with a maximum daily dose of 80 mL.
Infants and Children: 0.25-0.5 mg/kg 3-4 times/day with a maximum daily dose of 2.4 mg/kg (but do not exceed 80 mg/day).
Tablets are unsuitable for use in children weighing <35 kg.
Oral Suspension:
0.25-0.5 mg/kg 3-4 times/day with a maximum dose of 2.4 mg/kg (not exceeding 80 mL).
Peristar interactions
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Concomitant administration of anticholinergic drugs may antagonise the antidyspeptic effect of Peristar.
Antacids and antisecretory drugs should not be given simultaneously with oral formulations of Peristar as they lower its oral bioavailability.
The main metabolic pathway of Peristar is through CYP3A4. In vitro and human data show that the concomitant use of drugs that significantly inhibit this enzyme may result in increased plasma levels of Peristar. Examples of potent CYP3A4 inhibitors include: Azole antifungals eg, fluconazole*, itraconazole, ketoconazole* and voriconazole*; macrolide antibiotics eg, clarithromycin* and erythromycin*; HIV protease inhibitors eg, amprenavir, atazanavir, fosamprenavir, indinavir, nelfinavir, ritonavir and saquinavir; calcium antagonists eg, diltiazem and verapamil; amiodarone*; aprepitant; nefazodone; telithromycin*.
(*Also prolong the QTc interval; see Contraindications.)
Separate pharmacokinetic/pharmacodynamic interaction studies with oral ketoconazole or oral erythromycin in healthy subjects confirmed a marked inhibition of Peristar's CYP3A4 mediated first-pass metabolism by these drugs.
With the combination of Peristar 10 mg 4 times daily and ketoconazole 200 mg twice daily, a mean QTc prolongation of 9.8 msec was seen over the observation period, with changes at individual time points ranging from 1.2-17.5 msec. With the combination of Peristar 10 mg 4 times daily and erythromycin 500 mg 3 times daily, mean QTc over the observation period was prolonged by 9.9 msec, with changes at individual time points ranging from 1.6-14.3 msec. Both the Cmax and AUC of Peristar at steady-state were increased approximately 3-fold in each of these interaction studies.
The contribution of increased plasma concentrations of Peristar to the observed effect on QTc is not known.
In these studies, Peristar monotherapy at 10 mg 4 times daily resulted in increases in mean QTc of 1.6 msec (ketoconazole study) and 2.5 msec (erythromycin study), while ketoconazole monotherapy (200 mg twice daily) and erythromycin monotherapy (500 mg 3 times daily) led to increases in mean QTc of 3.8 and 4.9 msec, respectively, over the observation period.
In another multiple-dose study in healthy subjects, no significant increases in QTc were noted during steady-state treatment with Peristar monotherapy at 40 mg 4 times daily (total daily dose of 160 mg, which is double the maximum daily dose) at plasma concentrations of Peristar that were at least similar to those found in the combination arms of the interaction studies.
Theoretically, since Peristar has gastrokinetic effects, it could influence the absorption of concomitantly orally administered drugs, particularly those with sustained release or enteric-coated formulations. However, in patients already stabilised on digoxin or paracetamol, concomitant administration of Peristar did not influence the blood levels of these drugs.
Peristar may also be given with neuroleptics, the action of which it does not potentiate; dopaminergic agonists (bromocriptine, L-dopa), whose unwanted peripheral effects eg, digestive disorders, nausea and vomiting, it suppresses without counteracting their central properties.
Clinical Trial Data: The safety of Peristar was evaluated in 1221 patients with gastroparesis, dyspepsia, gastro-oesophageal reflux disorder (GERD) or other related conditions in 45 clinical trials included in the safety database. All patients were ≥15 years and received at least 1 dose of oral Peristar (Peristar base). Slightly fewer than one-half (553/1221) of patients were diabetic. The median total daily dose was 80 mg (range 10-160 mg), with 230 patients receiving a dose >80 mg. Median duration of exposure was 56 days (range 1-2248 days).
Adverse drug reactions (ADRs) reported by ≥1% of patients treated with oral Peristar in these 45 clinical trials (n=1221) are the following: Psychiatric Disorders: Depression (2.5%), anxiety (1.6%), decreased libido/loss of libido (1.5%).
Nervous System Disorders: Headache (5.6%), somnolence (2.5%), akathisia (1%).
Gastrointestinal Disorders: Diarrhoea (5.2%).
Skin and Subcutaneous Tissue Disorders: Rash (2.8%), pruritus (1.7%).
Reproductive System and Breast Disorders: Breast enlargement/gynaecomastia (5.3%), breast tenderness (4.4%), galactorrhoea (3.3%), amenorrhoea (2.9%), breast pain (2.3%), irregular menstruation (2%), lactation disorder (1.6%).
General Disorders and Administration Site Conditions: Asthenia (1.9%).
ADRs that occurred in <1% of Peristar-treated patients in the 45 clinical trials (n=1221) are the following: Immune System Disorders: Hypersensitivity (0.2%).
Skin and Subcutaneous Disorders: Urticaria (0.7%).
Reproductive System and Breast Disorders: Breast discharge (0.8%), breast swelling (0.5%).
Dry mouth has been reported with over-the-counter use of Peristar.
Post-Marketing: In addition to the adverse effects reported during clinical studies and previously mentioned, the following adverse drug reactions provided the frequencies according to the following convention: Very common (≥1/10), common (≥1/100 and <1/10); uncommon (≥1/1000 and <1/100); rare (≥1/10,000 and <1/1000); very rare (<1/10,000, including isolated reports).
The following ADRs are presented by frequency category based on spontaneous reporting rates: Immune System Disorders: Very Rare: Anaphylactic reactions (including anaphylactic shock).
Psychiatric Disorders: Very Rare: Agitation, nervousness.
Nervous System Disorders: Very Rare: Extrapyramidal disorder, convulsion.
Cardiac Disorders: Very Rare: Sudden cardiac death*, serious ventricular arrhythmias*.
Skin and Subcutaneous Tissue Disorders: Very Rare: Angioedema.
Renal and Urinary Disorders: Very Rare: Urinary retention.
Investigations: Very Rare: Abnormal liver function test; increased blood prolactin.
Note: *Based on epidemiology data (as follows).
As the hypophysis is outside the blood-brain barrier, Peristar may cause an increase in prolactin levels. In rare cases, this hyperprolactinaemia may lead to neuro-endocrinological side effects eg, galactorrhoea, gynaecomastia and amenorrhoea.
Extrapyramidal disorder occurs primarily in neonates and infants.
Other central nervous system-related effects of convulsion and agitation are also reported primarily in infants and children.
An increase in the risk of serious ventricular arrhythmias and sudden cardiac death has been reported in some epidemiology studies. Due to the limitations of these data, risk factors and the exact frequency of these adverse reactions could not be defined.
Peristar contraindications
Hypersensitivity to Peristar or any ingredient of Peristar.
If patients are taking oral ketoconazole, fluconazole, voriconazole, erythromycin, clarithromycin, telithromycin, amiodarone, selective serotonin reuptake inhibitors, HIV protease inhibitors, calcium antagonists which can increase plasma concentrations of Peristar, leading to a prolonged QTc interval. These medicines can increase plasma concentrations of Peristar leading to a prolonged QTc interval. Patients with long QT syndrome develop a very fast heart rhythm disturbance leading to a sudden loss of consciousness.
Gastrointestinal hemorrhage (bleeding), obstruction, perforation or conditions where gastrointestinal stimulation or movements may be dangerous.
DTP/NCI. "domperidone: 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).
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