What happens if I overdose Pramil?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately.
Proper storage of Pramil suspension:
Store Pramil suspension at room temperature below 86 degrees F (30 degrees C) or in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze. Throw away any unused medicine 60 days after it has been mixed. Keep Pramil suspension out of the reach of children and away from pets.
Overdose of Pramil in details
In studies of healthy volunteers given single doses up to 800 mg, adverse reaction were similar to those observed with lower doses but with a higher incidence. On careful clinical evaluation of the patient, from evaluation of the time that has elapsed from ingestion or administration of the amount of toxins ingested and leaving aside the fact that certain procedures are contraindicated, the healthcare professional should decide whether or not to give general rescue treatment ie, gastric lavage and administration of activated charcoal.
Clinical Monitoring and Support Treatment: Hemodialysis will not be of any value since Pramil and its active metabolite bind to plasma proteins. If an overdose is suspected, go to the nearest hospital or contact a toxicology center.
What should I avoid while taking Pramil?
Grapefruit and grapefruit juice may interact with Pramil and lead to unwanted side effects. Avoid the use of grapefruit products while taking Pramil.
Drinking alcohol can increase certain side effects of Pramil.
Avoid using any other medicines to treat impotence, such as alprostadil or yohimbine, without first talking to your doctor.
Pramil warnings
Mortality with Pediatric Use
In a long-term trial in pediatric patients with PAH, an increase in mortality with increasing Pramil dose was observed. Deaths were first observed after about 1 year and causes of death were typical of patients with PAH. Use of Pramil, particularly chronic use, is not recommended in children.
Hypotension
Pramil has vasodilatory properties, resulting in mild and transient decreases in blood pressure. Before prescribing Pramil, carefully consider whether patients with certain underlying conditions could be adversely affected by such vasodilatory effects (e.g., patients on antihypertensive therapy or with resting hypotension [BP less than 90/50], fluid depletion, severe left ventricular outflow obstruction, or autonomic dysfunction). Monitor blood pressure when co-administering blood pressure lowering drugs with Pramil.
Worsening Pulmonary Vascular Occlusive Disease
Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease (PVOD). Since there are no clinical data on administration of Pramil to patients with veno-occlusive disease, administration of Pramil to such patients is not recommended. Should signs of pulmonary edema occur when Pramil is administered, consider the possibility of associated PVOD.
Epistaxis
The incidence of epistaxis was 13% in patients taking Pramil with PAH secondary to CTD. This effect was not seen in idiopathic PAH (Pramil 3%, placebo 2%) patients. The incidence of epistaxis was also higher in Pramil-treated patients with a concomitant oral vitamin K antagonist (9% versus 2% in those not treated with concomitant vitamin K antagonist).
The safety of Pramil is unknown in patients with bleeding disorders or active peptic ulceration.
Visual Loss
When used to treat erectile dysfunction, non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported postmarketing in temporal association with the use of phosphodiesterase type 5 (PDE-5) inhibitors, including Pramil. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. Based on published literature, the annual incidence of NAION is 2.5–11.8 cases per 100,000 males aged ≥ 50 per year in the general population. An observational study evaluated whether recent, episodic use of PDE5 inhibitors (as a class), typical of erectile dysfunction treatment, was associated with acute onset of NAION. The results suggest an approximately 2-fold increase in the risk of NAION within 5 half-lives of PDE5 inhibitor use. It is not possible to determine whether these events are related directly to the use of PDE-5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors. Advise patients to seek immediate medical attention in the event of a sudden loss of vision in one or both eyes while taking PDE-5 inhibitors, including Pramil. Physicians should also discuss the increased risk of NAION with patients who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE-5 inhibitors.
There are no controlled clinical data on the safety or efficacy of Pramil in patients with retinitis pigmentosa, a minority whom have genetic disorders of retinal phosphodiesterases. Prescribe Pramil with caution in these patients.
Hearing Loss
Cases of sudden decrease or loss of hearing, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with the use of PDE-5 inhibitors, including Pramil. In some of the cases, medical conditions and other factors were reported that may have played a role. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of Pramil, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors.
Advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking PDE-5 inhibitors, including Pramil.
Combination with other PDE-5 inhibitors
Pramil is also marketed as Pramil®. The safety and efficacy of combinations of Pramil with Pramil or other PDE-5 inhibitors have not been studied. Inform patients taking Pramil not to take Pramil or other PDE-5 inhibitors.
Priapism
Use Pramil with caution in patients with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease) or in patients who have conditions, which may predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia). In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism (painful erection greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.
Vaso-occlusive Crisis in Patients with Pulmonary Hypertension Secondary to Sickle Cell Anemia
In a small, prematurely terminated study of patients with pulmonary hypertension (PH) secondary to sickle cell disease, vaso-occlusive crises requiring hospitalization were more commonly reported by patients who received Pramil than by those randomized to placebo. The effectiveness and safety of Pramil in the treatment of PAH secondary to sickle cell anemia has not been established.
What should I discuss with my healthcare provider before taking Pramil?
You should not use Pramil if you are allergic to Pramil, or:
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if you take other medicines to treat pulmonary arterial hypertension, such as riociguat (Adempas).
Do not take Pramil if you are also using a nitrate drug for chest pain or heart problems. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers"). Taking Pramil with a nitrate medicine can cause a sudden and serious decrease in blood pressure.
To make sure Pramil is safe for you, tell your doctor about your other medical conditions, especially:
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heart disease or heart rhythm problems, coronary artery disease;
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a recent history (in the past 6 months) of a heart attack, stroke, or congestive heart failure;
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high or low blood pressure;
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liver or kidney disease;
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a blood cell disorder such as sickle cell anemia, multiple myeloma, or leukemia;
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a bleeding disorder such as hemophilia;
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a stomach ulcer;
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retinitis pigmentosa (an inherited condition of the eye);
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a physical deformity of the penis (such as Peyronie's disease); or
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if you have been told you should not have sexual intercourse for health reasons.
Pramil can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. This has occurred in a small number of people taking Pramil, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoked or were over 50 years old. It is not clear whether Pramil is the actual cause of vision loss.
Pramil is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
It is not known whether Pramil passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.
Do not give Pramil to anyone under 18 years old without medical advice.
Pramil precautions
The efficacy of Pramil has not been established in patients with severe PAH (functional class IV). If the clinical situation deteriorates, therapies that are recommended at the severe stage of the disease (eg, epoprostenol) should be considered. The benefit-risk balance of Pramil has not been established in patients with class I functional classification of PAH.
Studies with Pramil have been performed in forms of PAH related to primary (idiopathic), connective tissue disease associated or congenital heart disease associated forms of PAH. The use of Pramil in other forms of PAH is not recommended.
Retinitis Pigmentosa: The safety of Pramil has not been studied in patients with known hereditary degenerative retinal disorders eg, retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases) and therefore, its use is not recommended.
Vasodilatory Action: When prescribing Pramil, physicians should carefully consider whether patients with certain underlying conditions could be adversely affected by Pramil's mild to moderate vasodilatory effects eg, patients with hypotension, patients with fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction.
Cardiovascular Risk Factors: In post-marketing experience with Pramil for male erectile dysfunction, serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported in temporal association with the use of Pramil. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of Pramil without sexual activity. It is not possible to determine whether these events are related directly to these factors or to other factors.
Priapism: Pramil should be used with caution in patients with anatomical deformation of the penis (eg, angulation, cavernosal fibrosis or Peyronie's disease) or in patients who have conditions which may predispose them to priapism (eg, sickle cell anaemia, multiple myeloma or leukaemia).
Vaso-Occlusive Crises in Patients with Sickle Cell Anaemia: Pramil should not be used in patients with pulmonary hypertension secondary to sickle cell anaemia. In a clinical study, events of vaso-occlusive crises requiring hospitalisation were reported more commonly by patients receiving Pramil than those receiving placebo leading to the premature termination of this study.
Visual Events: Visual defects and cases of NAION have been reported in connection with the intake of Pramil and other PDE5 inhibitors. The patient should be advised that in case of sudden visual defect, the patient should stop taking Pramil and consult a physician immediately.
Alpha-Blockers: Caution is advised when Pramil is administered to patients taking an α-blocker as the co-administration may lead to symptomatic hypotension in susceptible individuals. In order to minimise the potential for developing postural hypotension, patients should be haemodynamically stable on α-blocker therapy prior to initiating Pramil treatment. Physicians should advise patients what to do in the event of postural hypotensive symptoms.
Bleeding Disorders: Studies with human platelets indicate that Pramil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. There is no safety information on the administration of Pramil to patients with bleeding disorders or active peptic ulceration. Therefore, Pramil should be administered to these patients only after careful benefit-risk assessment.
Vitamin K Antagonists: In PAH patients, there may be a potential for increased risk of bleeding when Pramil is initiated in patients already using a Vitamin K antagonist, particularly in patients with PAH secondary to connective tissue disease.
Veno-Occlusive Disease: No data are available with Pramil in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease. However, cases of life-threatening pulmonary oedema have been reported with vasodilators (mainly prostacyclin) when used in those patients. Consequently, should signs of pulmonary oedema occur when Pramil is administered in patients with pulmonary hypertension, the possibility of associated veno-occlusive disease should be considered.
Galactose Intolerance: Lactose monohydrate is present in the tablet film coat. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Effects on the Ability to Drive or Operate Machinery: Pramil has moderate influence on the ability to drive and use machines.
As dizziness and altered vision were reported in clinical trials with Pramil, patients should be aware of how they might be affected by Pramil, before driving or operating machinery.
Impairment of Fertility: Non-clinical data revealed no special hazard for humans based on conventional studies of fertility.
Use in pregnancy: There are no data from the use of Pramil in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy and embryonal/foetal development. Studies in animals have shown toxicity with respect to postnatal development.
Due to lack of data, Pramil should not be used in pregnant women unless strictly necessary.
Women of childbearing Potential and Contraception in Males and Females: Due to lack of data on effects of Pramil in pregnant women, Pramil is not recommended for women of childbearing potential unless also using appropriate contraceptive measures.
Use in lactation: It is not known whether Pramil enters the breast milk. Pramil should not be administered to breastfeeding mothers.
Use in children (<18 years): The safety and efficacy in children and adolescents have not been studied in large controlled clinical trials. Therefore, the use of Pramil is not recommended in these patients.
What happens if I miss a dose of Pramil?
Since Pramil is used as needed, you are not likely to miss a dose.
If you miss a dose of Pramil, 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.
References
- DailyMed. "SECOBARBITAL SODIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "metoclopramide". http://www.drugbank.ca/drugs/DB01233 (accessed September 17, 2018).
- DrugBank. "secobarbital". http://www.drugbank.ca/drugs/DB00418 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
