Pcp 100 Kit
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Questions & Answers
Side Effects & Adverse Reactions
Warnings
Do not use if you are on a low salt diet
Ask a doctor before use if you have
- kidney disease
- a magnesium or sodium restricted diet
- abdorominal pain, nausea, or vomiting
- noticed a sudden change in bowel habits tat persists over a period of 2 weeks
- already used a laxative for a period longer than 1 week
Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.
Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement afte use. These could be signs of a serious condition.
Do not use if you cannot swallow without chewing
-you have a sudden change in bowel habits that lasts more than 2 weeks
-stomach pain, nausea or vomiting
-do not use within 1 hour after taking an antacid or milk
-do not chew or crush tablet(s)
-you may have stomach discomfort, faintness or cramps
-you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
-you need to use a laxative for more than 1 week
ask a health professions before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Do not use if you cannot swallow without chewing
Ask a doctor before use if-you have a sudden change in bowel habits that lasts more than 2 weeks
-stomach pain, nausea or vomiting
Stop use and ask a doctor if-you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.
-you need to use a laxative for more than 1 week
For External Use Only
Do Not Get In Eyes
- If condition worsens
- symptoms last more than 7 days or clear up and occur again in a few days
Do not use on:
- Deep or puncture wounds
- animal bites
- serious burns
Allergy alert: Do not use if you are allergic to polyethylene glycol
Do not use if you have kidney disease, except under the advice and supervision of a doctor
- nausea, vomiting or abdominal pain
- a sudden change in bowel habits that lasts over 2 weeks
- irritable bowel syndrome
Ask a doctor or pharmacist before use if you are taking a prescription drug
When using this product you may have loose, watery, more frequent stools
Mental depression has occurred in patients with and without prior history of depression. Symptoms have ranged from mild to severe and have included suicidal ideation and suicide. Metoclopramide should be given to patients with a prior history of depression only if the expected benefits outweigh the potential risks.
Extrapyramidal symptoms, manifested primarily as acute dystonic reactions, occur in approximately 1 in 500 patients treated with the usual adult dosages of 30 to 40 mg/day of metoclopramide. These usually are seen during the first 24 to 48 hours of treatment with metoclopramide, occur more frequently in pediatric patients and adult patients less than 30 years of age and are even more frequent at higher doses. These symptoms may include involuntary movements of limbs and facial grimacing, torticollis, oculogyric crisis, rhythmic protrusion of tongue, bulbar type of speech, trismus, or dystonic reactions resembling tetanus. Rarely, dystonic reactions may present as stridor and dyspnea, possibly due to laryngospasm. If these symptoms should occur, inject 50 mg diphenhydramine hydrochloride intramuscularly, and they usually will subside. Benztropine mesylate, 1 to 2 mg intramuscularly, may also be used to reverse these reactions.
Parkinsonian-like symptoms have occurred, more commonly within the first 6 months after beginning treatment with metoclopramide, but occasionally after longer periods. These symptoms generally subside within 2 to 3 months following discontinuance of metoclopramide. Patients with preexisting Parkinson’s disease should be given metoclopramide cautiously, if at all, since such patients may experience exacerbation of parkinsonian symptoms when taking metoclopramide.
Treatment with metoclopramide can cause tardive dyskinesia (TD), a potentially irreversible and disfiguring disorder characterized by involuntary movements of the face, tongue, or extremities. The risk of developing tardive dyskinesia increases with the duration of treatment and the total cumulative dose. An analysis of utilization of patterns showed that about 20% of patients who used metoclopramide took it longer than 12 weeks. Treatment with metoclopramide for longer than the recommended 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing TD.
Although the risk of developing TD in the general population may be increased among the elderly, women, and diabetics, it is not possible to predict which patients will develop metoclopramide-induced TD. Both the risk of developing TD and the likelihood that TD will become irreversible increase with duration of treatment and total cumulative dose.
Metoclopramide should be discontinued in patients who develop signs and symptoms of TD. There is no known effective treatment for established cases of TD, although in some patients, TD may remit, partially or completely, within several weeks to months after metoclopramide is withdrawn.
Metoclopramide itself may suppress, or partially suppress, the signs of TD, thereby masking the underlying disease process. The effect of this symptomatic suppression upon the long-term course of TD is unknown. Therefore, metoclopramide should not be used for the symptomatic control of TD.
There have been rare reports of an uncommon but potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) associated with metoclopramide. Clinical manifestations of NMS include hyperthermia, muscle rigidity, altered consciousness, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis and cardiac arrhythmias).
The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, malignant hyperthermia, drug fever and primary central nervous system (CNS) pathology.
The management of NMS should include 1) immediate discontinuation of metoclopramide and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. Bromocriptine and dantrolene sodium have been used in treatment of NMS, but their effectiveness have not been established (see ADVERSE REACTIONS).
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Use for relief of occasional constipation (irregularity). Generally produces bowel movement in 1/2 to 6 hours
-relieves occasional constipation and irregularity
-this product generally produces bowel movement in 6 to 12 hours
Indications and Usage
A skin protectant for the treatment of diaper rash, minor cuts, scrapes, burns and to help relieve chapped and cracked skin and lips.
- do not take more than directed unless advised by your doctor
- the bottle top is a measuring cap marked to contain 17 grams of powder when filled to the indicated line.
- adults and children 17 years of age and older:
- fill to top of line in cap which is marked to indicate the correct dose (17 g)
- stir and dissolve in any 4 to 8 ounces of beverage (cold, hot or room temperature) then drink
- use once a day
- use no more than 7 days
- children 16 years of age or under: ask a doctor
Other Information
- store at 20°- 25°C (68°– 77°F)
- tamper-evident: do not use if printed foil seal under cap is missing, open or broken
The use of metoclopramide tablets is recommended for adults only. Therapy should not exceed 12 weeks in duration.
Metoclopramide tablets are indicated as short-term (4 to 12 weeks) therapy for adults with symptomatic, documented gastroesophageal reflux who fail to respond to conventional therapy.
The principal effect of metoclopramide is on symptoms of postprandial and daytime heartburn with less observed effect on nocturnal symptoms. If symptoms are confined to particular situations, such as following the evening meal, use of metoclopramide as single doses prior to the provocative situation should be considered, rather than using the drug throughout the day. Healing of esophageal ulcers and erosions has been endoscopically demonstrated at the end of a 12 week trial using doses of 15 mg q.i.d. As there is no documented correlation between symptoms and healing of esophageal lesions, patients with documented lesions should be monitored endoscopically.
Metoclopramide tablets are indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis. The usual manifestations of delayed gastric emptying (e.g., nausea, vomiting, heartburn, persistent fullness after meals, and anorexia) appear to respond to metoclopramide within different time intervals. Significant relief of nausea occurs early and continues to improve over a three-week period. Relief of vomiting and anorexia may precede the relief of abdominal fullness by one week or more.
History
There is currently no drug history available for this drug.
Other Information
Metoclopramide hydrochloride is a white or practically white, crystalline, odorless or practically odorless powder. It is very soluble in water, freely soluble in alcohol, sparingly soluble in chloroform and practically insoluble in ether. Chemically, it is 4-amino-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxy benzamide monohydrochloride monohydrate. Its structural formula is as follows:
C14H22ClN3O2 •HCl•H2O M.W. 354.3
Each tablet for oral administration contains 5 mg or 10 mg metoclopramide (present as the hydrochloride).
Corn starch, dibasic calcium phosphate, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
Sources
Pcp 100 Kit Manufacturers
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Asclemed Usa, Inc.
![Pcp 100 Kit (Magesium Citrate, Bisacodyl, Petrolatum, Polyethylene Glycol 3350, Metoclopramide) Kit [Asclemed Usa, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Pcp 100 Kit | Asclemed Usa, Inc.
Directions
drink a full glass (8 ounces) of liquid with each dose may be taken as a single daily dose or in divided dosesadults and children 12 years of age and over - 6.5 to 10 fl oz in 24 hours
children 6 to under 12 years of age - 3 to 7 fl oz maximum 7 fl oz in 24 hours
children 2 to under 6 years of age - 2 to 3 fl oz
children under 2 years of age - ask a doctor
discard unused product within 24 hours of opening bottle
-take with a glass of water
adults and children 12 years and over- take 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age - take 1 tablet in a single daily dose
children under 6 years of age - ask a doctor
Change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply as needed
you have rectal bleeding or your nausea, bloating, cramping or abdominal pain gets worse. These may be signs of a serious condition. you get diarrhea you need to use a laxative for longer than 1 weekIf pregnant or breast-feeding, ask a health professional before use.
Therapy with metoclopramide tablets, USP should not exceed 12 weeks in duration.
For the Relief of Symptomatic Gastroesophageal RefluxAdminister from 10 mg to 15 mg of metoclopramide tablet, USP orally up to q.i.d. 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response (see CLINICAL PHARMACOLOGY and INDICATIONS AND USAGE). If symptoms occur only intermittently or at specific times of the day, use of metoclopramide in single doses up to 20 mg prior to the provoking situation may be preferred rather than continuous treatment. Occasionally, patients (such as elderly patients) who are more sensitive to the therapeutic or adverse effects of metoclopramide will require only 5 mg per dose.
Experience with esophageal erosions and ulcerations is limited, but healing has thus far been documented in one controlled trial using q.i.d. therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated (see ADVERSE REACTIONS). Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.
Therapy longer than 12 weeks has not been evaluated and cannot be recommended.
For the Relief of Symptoms Associated With Diabetic Gastroparesis (Diabetic Gastric Stasis)Administer 10 mg of metoclopramide 30 minutes before each meal and at bedtime for two to eight weeks, depending upon response and the likelihood of continued well-being upon drug discontinuation.
The initial route of administration should be determined by the severity of the presenting symptoms. If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide tablets, USP may be initiated. However, if severe symptoms are present, therapy should begin with metoclopramide injection (consult labeling of the injection prior to initiating parenteral administration).
Administration of metoclopramide injection up to 10 days may be required before symptoms subside, at which time oral administration may be instituted. Since diabetic gastric stasis is frequently recurrent, metoclopramide tablet, USP therapy should be reinstituted at the earliest manifestation.
Use in Patients With Renal or Hepatic ImpairmentSince metoclopramide is excreted principally through the kidneys, in those patients whose creatinine clearance is below 40 mL/min, therapy should be initiated at approximately one-half the recommended dosage. Depending upon clinical efficacy and safety considerations, the dosage may be increased or decreased as appropriate.
See OVERDOSAGE section for information regarding dialysis.
Metoclopramide undergoes minimal hepatic metabolism, except for simple conjugation. Its safe use has been described in patients with advanced liver disease whose renal function was normal.
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