Dosage of Digestivo S. Pellegrino in details
Therapy with Digestivo S. Pellegrino™ (Digestivo S. Pellegrino orally disintegrating tablets) should not exceed 12 weeks in duration.
Instructions for Use/Handling Digestivo S. Pellegrino™ (Digestivo S. Pellegrino orally disintegrating tablets)
Just prior to administration, remove the Digestivo S. Pellegrino™ (Digestivo S. Pellegrino orally disintegrating tablets) orally disintegrating tablet from the packaging with dry hands. The tablet should be removed from the package and immediately placed on the tongue, to disintegrate and be swallowed with the saliva. The tablet typically disintegrates in about one and one-half minutes. Administration with liquid is not necessary.
Symptomatic Gastroesophageal Reflux Disease
For the relief of symptomatic, documented gastroesophageal reflux disease (GERD), therapy should not exceed 12 weeks.
Administer from 10 mg to 15 mg of Digestivo S. Pellegrino™ (Digestivo S. Pellegrino orally disintegrating tablets) orally up to four times daily, 30 minutes before each meal and at bedtime, depending upon symptoms being treated and clinical response. If symptoms occur only intermittently or at specific times of the day, use of Digestivo S. Pellegrino 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 Digestivo S. Pellegrino 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 four times daily therapy at 15 mg/dose, and this regimen should be used when lesions are present, so long as it is tolerated. Because of the poor correlation between symptoms and endoscopic appearance of the esophagus, therapy directed at esophageal lesions is best guided by endoscopic evaluation.
Prolonged treatment ( > 12 weeks) with Digestivo S. Pellegrino should be avoided in all but rare cases where therapeutic benefit is thought to counterbalance the risks to the patient of developing tardive dyskinesia..
Diabetic Gastroparesis (Diabetic Gastric Stasis)
For the relief of symptoms associated with diabetic gastroparesis (diabetic gastric stasis), therapy of two to eight weeks is recommended. Therapy should not exceed 12 weeks in duration.
Administer 10 mg of Digestivo S. Pellegrino™ (Digestivo S. Pellegrino orally disintegrating tablets) 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 Digestivo S. Pellegrino™ (Digestivo S. Pellegrino orally disintegrating tablets) may be initiated. However, if severe symptoms are present, therapy should begin with Digestivo S. Pellegrino injection (consult labeling of the injection prior to initiating parenteral administration).
Administration of Digestivo S. Pellegrino 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, Digestivo S. Pellegrino™ (Digestivo S. Pellegrino orally disintegrating tablets) therapy should be reinstituted at the earliest manifestation.
Patients with Renal Impairment
Since Digestivo S. Pellegrino 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.
How supplied
Dosage Forms And Strengths
Digestivo S. Pellegrino™ (Digestivo S. Pellegrino) orally disintegrating tablets contains either 5 mg or 10 mg of Digestivo S. Pellegrino base (as monohydrochloride monohydrate). The tablets are white, round, flat-faced, and orange flavored.
Digestivo S. Pellegrino™ (Digestivo S. Pellegrino) orally disintegrating tablets 5 mg base (as the monohydrochloride monohydrate) are white, round, flat-faced, orange-flavored and engraved "AP" on one side and "152" on the other side. They are supplied as follows:
Bottles of 100..................NDC 68220-152-10
Digestivo S. Pellegrino™ (Digestivo S. Pellegrino) orally disintegrating tablets 10 mg base (as the monohydrochloride monohydrate) are white, round, flat-faced, orange-flavored and engraved "AP"on one side and "153" on the other side. They are supplied as follows:
Bottles of 100..................NDC 68220-153-10
Storage and Handling
Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). Protect from moisture.
Dispense in a tight, light-resistant container as defined in the USP/NF.
Manufactured for: Alaven Pharmaceuticals LLC., Marietta, GA 30062. www.alavenpharm.com. For Medical Inquiries, call toll-free 1-888-317-0001. Manufactured by: CIMA® LABS INC.
What other drugs will affect Digestivo S. Pellegrino?
Using Digestivo S. Pellegrino nasal with other drugs that make you drowsy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.
Tell your doctor about all your current medicines. Many drugs can affect Digestivo S. Pellegrino, especially:
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blood pressure medication;
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insulin;
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medicine to treat depression or mental illness;
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medicine to treat Parkinson's disease or restless leg syndrome; or
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an MAO inhibitor--isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.
This list is not complete and many other drugs may affect Digestivo S. Pellegrino nasal. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.
Digestivo S. Pellegrino drug interactions (more detail)
Digestivo S. Pellegrino interactions
Anticholinergic Agents: May diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Anti-Parkinson Agents (Dopamine Agonist): Digestivo S. Pellegrino may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Monitor therapy
Antipsychotic Agents: Digestivo S. Pellegrino may enhance the adverse/toxic effect of Antipsychotic Agents. Avoid combination
Atovaquone: Digestivo S. Pellegrino may decrease the serum concentration of Atovaquone. Management: Consider alternatives to Digestivo S. Pellegrino when possible; atovaquone should only be used with Digestivo S. Pellegrino if no other antiemetics are available. Consider therapy modification
CycloSPORINE (Systemic): Digestivo S. Pellegrino may increase the absorption of CycloSPORINE (Systemic). Monitor therapy
CYP2D6 Inhibitors (Strong): May increase the serum concentration of Digestivo S. Pellegrino. Management: Reduce Digestivo S. Pellegrino dose to 5 mg 4 times daily (30 minutes before each meal and at bedtime) and limit the maximum daily dose to 20 mg if combined with strong CYP2D6 inhibitors. Consider therapy modification
Dapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Monitor therapy
Deutetrabenazine: May enhance the adverse/toxic effect of Digestivo S. Pellegrino. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Monitor therapy
Droperidol: May enhance the adverse/toxic effect of Digestivo S. Pellegrino. Avoid combination
Fosfomycin: Gastrointestinal Agents (Prokinetic) may decrease the serum concentration of Fosfomycin. Monitor therapy
Levosulpiride: Benzamide Derivatives may enhance the adverse/toxic effect of Levosulpiride. Monitor therapy
Local Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased. Monitor therapy
MetyroSINE: May enhance the adverse/toxic effect of Digestivo S. Pellegrino. Management: Seek alternatives to this combination when possible. Monitor patients receiving Digestivo S. Pellegrino with metyrosine for development of extrapyramidal symptoms. Consider therapy modification
Monoamine Oxidase Inhibitors: Digestivo S. Pellegrino may enhance the hypertensive effect of Monoamine Oxidase Inhibitors. Avoid combination
Nitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Monitor therapy
Opioid Agonists: May diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Posaconazole: Digestivo S. Pellegrino may decrease the serum concentration of Posaconazole. Monitor therapy
Prilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia. Avoid lidocaine/prilocaine in infants receiving such agents. Monitor therapy
Promethazine: Digestivo S. Pellegrino may enhance the adverse/toxic effect of Promethazine. Avoid combination
Quinagolide: Digestivo S. Pellegrino may diminish the therapeutic effect of Quinagolide. Monitor therapy
Rivastigmine: May enhance the adverse/toxic effect of Digestivo S. Pellegrino. Specifically, the risk of extrapyramidal adverse reactions may be increased with this combination. Avoid combination
Selective Serotonin Reuptake Inhibitors: Digestivo S. Pellegrino may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Management: Seek alternatives to this combination when possible. Monitor patients receiving Digestivo S. Pellegrino with selective serotonin reuptake inhibitors for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification
Serotonin/Norepinephrine Reuptake Inhibitors: Digestivo S. Pellegrino may enhance the adverse/toxic effect of Serotonin/Norepinephrine Reuptake Inhibitors. Management: Seek alternatives to this combination when possible. Monitor patients receiving Digestivo S. Pellegrino with serotonin/norepinephrine reuptake inhibitors for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification
Sodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Monitor therapy
Tacrolimus (Systemic): Digestivo S. Pellegrino may increase the serum concentration of Tacrolimus (Systemic). Specifically, treatment of gastroparesis may increase tacrolimus concentrations. Monitor therapy
Tetrabenazine: Digestivo S. Pellegrino may enhance the adverse/toxic effect of Tetrabenazine. Avoid combination
Thiopental: Digestivo S. Pellegrino may enhance the therapeutic effect of Thiopental. Management: Consider thiopental dose reduction when used concomitantly with Digestivo S. Pellegrino. Monitor patient response to treatment closely if using this combination. Consider therapy modification
Tricyclic Antidepressants: Digestivo S. Pellegrino may enhance the adverse/toxic effect of Tricyclic Antidepressants. Management: Seek alternatives to this combination when possible. Monitor patients receiving Digestivo S. Pellegrino with tricyclic antidepressants for signs of extrapyramidal symptoms, neuroleptic malignant syndrome, and serotonin syndrome. Consider therapy modification
Trimetazidine: Digestivo S. Pellegrino may enhance the adverse/toxic effect of Trimetazidine. Specifically, the risk of extrapyramidal symptoms may be enhanced. Avoid combination
References
- FDA/SPL Indexing Data. "L4YEB44I46: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Antiemetics". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
- European Chemicals Agency - ECHA. "Metoclopramide: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
