Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include decreased urination; nausea; severe constipation or drowsiness; vomiting.
Proper storage of Loppa solution:
Store Loppa solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Loppa solution out of the reach of children and away from pets.
Overdose of Loppa in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
sponsored
In cases of overdosage, (including relative overdose due to hepatic dysfunction), urinary retention, paralytic ileus and CNS depression may occur. Children may be more sensitive to CNS effects than adults. Clinical trials have demonstrated that a slurry of activated charcoal administered promptly after ingestion of Loppa hydrochloride can reduce the amount of drug which is absorbed into the systemic circulation by as much as ninefold. If vomiting occurs spontaneously upon ingestion, a slurry of 100 gms of activated charcoal should be administered orally as soon as fluids can be retained.
If vomiting has not occurred, gastric lavage should be performed followed by administration of 100 gms of the activated charcoal slurry through the gastric tube. In the event of overdosage, patients should be monitored for signs of CNS depression for at least 24 hours.
If symptoms of overdose occur, naloxone can be given as an antidote. If responsive to naloxone, vital signs must be monitored carefully for recurrence of symptoms of drug overdose for at least 24 hours after the last dose of naloxone.
In view of the prolonged action of Loppa and the short duration (one to three hours) of naloxone, the patient must be monitored closely and treated repeatedly with naloxone as indicated. Since relatively little drug is excreted in the urine, forced diuresis is not expected to be effective for Loppa® (Loppa hydrochloride) overdosage.
In clinical trials an adult who took three 20mg doses within a 24 hour period was nauseated after the second dose and vomited after the third dose. In studies designed to examine the potential for side effects, intentional ingestion of up to 60 mg of Loppa hydrochloride in a single dose to healthy subjects resulted in no significant adverse effects.
What should I avoid while taking Loppa?
Loppa may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink.
Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you are taking an antibiotic and you have diarrhea that is watery or has blood in it, call your doctor. Do not use Loppa to stop the diarrhea unless your doctor has told you to.
Loppa warnings
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
sponsored
Fluid and electrolyte depletion often occur in patients who have diarrhea. In such cases, administration of appropriate fluid and electrolytes is very important. The use of Loppa® (Loppa hcl) does not preclude the need for appropriate fluid and electrolyte therapy.
In general, Loppa (Loppa hcl) should not be used when inhibition of peristalsis is to be avoided due to the possible risk of significant sequelae including ileus, megacolon and toxic megacolon. Loppa (Loppa hcl) must be discontinued promptly when constipation, abdominal distention or ileus develop.
Treatment of diarrhea with Loppa (Loppa hcl) is only symptomatic. Whenever an underlying etiology can be determined, specific treatment should be given when appropriate (or when indicated).
Patients with AIDS treated with Loppa (Loppa hcl) for diarrhea should have therapy stopped at the earliest signs of abdominal distention. There have been isolated reports of toxic megacolon in AIDS patients with infectious colitis from both viral and bacterial pathogens treated with Loppa hydrochloride. {ref EDMS-PSDB-2564186, pg 12}
Loppa® (Loppa hcl) should be used with special caution in young children because of the greater variability of response in this age group. Dehydration, particularly in younger children, may further influence the variability of response to Loppa® (Loppa hcl).
What should I discuss with my healthcare provider before taking Loppa?
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 Loppa, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to Loppa or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Loppa should not be used in children under 6 years of age unless directed by a doctor. Children, especially very young children, are very sensitive to the effects of Loppa. This may increase the chance of side effects during treatment. Also, the fluid loss caused by diarrhea may result in a serious health problem (dehydration). Loppa may hide the symptoms of dehydration. For these reasons, do not give medicine for diarrhea to children without first checking with their doctor. If you have any questions about this, check with your health care professional.
Geriatric
The fluid loss caused by diarrhea may result in a serious health problem (dehydration). Loppa may hide the symptoms of dehydration. For this reason, elderly persons with diarrhea, in addition to using medicine for diarrhea, must receive a sufficient amount of liquids to replace the fluid lost by the body. If you have any questions about this, check with your health care professional.
Pregnancy
Pregnancy Category
Explanation
All Trimesters
B
Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.
Breast Feeding
Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.
Interactions with 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. When you are taking Loppa, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using Loppa with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Eliglustat
Lomitapide
Nilotinib
Saquinavir
Simeprevir
Tocophersolan
Using Loppa with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Gemfibrozil
Itraconazole
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of Loppa. Make sure you tell your doctor if you have any other medical problems, especially:
Colitis (severe)—A more serious problem of the colon may develop if you use Loppa
Dysentery—This condition may get worse; a different kind of treatment may be needed
Liver disease—The chance of severe central nervous system (CNS) side effects may be greater in patients with liver disease
Loppa precautions
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
sponsored
General
Extremely rare allergic reactions including anaphylaxis and anaphylactic shock have been reported. In acute diarrhea, if clinical improvement is not observed in 48 hours, the administration of Loppa® (Loppa hydrochloride) should be discontinued and patients should be advised to consult their physician. Although no pharmacokinetic data are available in patients with hepatic impairment, Loppa should be used with caution in such patients because of reduced first pass metabolism. Patients with hepatic dysfunction should be monitored closely for signs of CNS toxicity. No pharmacokinetic data are available in patients with renal impairment. Since it has been reported that the majority of the drug is metabolized and metabolites or the unchanged drug is excreted mainly in the feces, dosage adjustments in patients with renal impairment are not required. No formal studies have been conducted to evaluate the pharmacokinetics of Loppa in elderly subjects. However, in two studies that enrolled elderly patients, there were no major differences in the drug disposition in elderly patients with diarrhea relative to young patients.
Information for Patients
Patients should be advised to check with their physician if their diarrhea does not improve in 48 hours or if they note blood in their stools, develop a fever or develop abdominal distention. Tiredness, dizziness, or drowsiness may occur in the setting of diarrheal syndromes treated with Loppa. Therefore, it is advisable to use caution when driving a car or operating machinery..
Drug Interactions
Nonclinical data have shown that Loppa is a P-glycoprotein substrate. Concomitant administration of Loppa (16 mg single dose) with a 600 mg single dose of either quinidine, or ritonavir, both of which are P-glycoprotein inhibitors, resulted in a 2- to 3- fold increase in Loppa plasma levels. Due to the potential for enhanced central effects when Loppa is coadministered with quinidine and with ritonavir, caution should be exercised when Loppa is administered at the recommended dosages (2 mg, up to 16 mg maximum daily dose) with P-glycoprotein inhibitors.
When a single 16-mg dose of Loppa is coadministered with a 600 mg single dose of saquinavir, Loppa decreased saquinavir exposure by 54%, which may be of clinical relevance due to reduction of therapeutic efficacy of saquinavir. The effect of saquinavir on Loppa is of less clinical significance. Therefore, when Loppa is given with saquinavir, the therapeutic efficacy of saquinavir should be closely monitored.
Carcinogenesis, mutagenesis, impairment of fertility
In an 18-month rat study with oral doses up to 40 mg/kg/day (21 times the maximum human dose of 16 mg/day, based on a body surface area comparison), there was no evidence of carcinogenesis.
Loppa was not genotoxic in the Ames test, the SOS chromotest in E. coli, the dominant lethal test in female mice, or the mouse embryo cell transformation assay.
Fertility and reproductive performance was evaluated in rats using oral doses of 2.5, 10, and 40 mg/kg/day (females only) in a second study.
Oral administration of 20 mg/kg/day (approximately 11 times the human dose based on a body surface area comparison) and higher produced strong impairment of female fertility. Treatment of female rats with up to 10 mg/kg/day by mouth (approximately 5 times the human dose based on a body surface area comparison) had no effect on fertility. Treatment of male rats with 40 mg/kg/day by mouth (approximately 21 times the human dose based on a body surface area comparison) produced impairment of male fertility, whereas administration of up to 10 mg/kg/day (approximately 5 times the human dose based on a body surface area comparison) had no effect.
Pregnancy
Teratogenic Effects
Pregnancy Category C
Teratology studies have been performed in rats using oral doses of 2.5, 10, and 40 mg/kg/day, and in rabbits using oral doses of 5, 20, and 40 mg/kg/day. These studies have revealed no evidence of impaired fertility or harm to the fetus at doses up to 10 mg/kg/day in rats (5 times the human dose based on body surface area comparison) and 40 mg/kg/day in rabbits (43 times the human dose based on body surface area comparison). Treatment of rats with 40 mg/kg/day by mouth (21 times the human dose based on a body surface area comparison) produced marked impairment of fertility. The studies produced no evidence of teratogenic activity. There are no adequate and well-controlled studies in pregnant women. Loppa should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Non-teratogenic Effects
In a peri- and post-natal reproduction study in rats, oral administration of 40 mg/kg/day produced impairment of growth and survival of offspring.
Nursing Mothers
Small amounts of Loppa may appear in human breast milk. Therefore, Loppa is not recommended during breast-feeding.
Pediatric Use
What happens if I miss a dose of Loppa?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Since Loppa is taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
