Epifenac 0.1% Overdose

How do you administer this medicine?
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What happens if I overdose Epifenac 0.1%?

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Epifenac 0.1% patch may be harmful if swallowed.

Proper storage of Epifenac 0.1% patch:

Store Epifenac 0.1% patch at 77 degrees F (25 degrees C) in the sealed pouch. Brief storage between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Throw away any unused patches 3 months after opening the pouch. The pouch is not child-resistant. Keep Epifenac 0.1% patch out of the reach of children and away from pets.

Overdose of Epifenac 0.1% 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.
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Symptoms: There is no typical clinical picture resulting from Epifenac 0.1% overdosage. Overdosage can cause symptoms such as vomiting, gastrointestinal hemorrhage, diarrhea, dizziness, tinnitus or convulsions. In the event of significant poisoning, acute renal failure and liver damage are possible.

Therapeutic Measures: Management of acute poisoning with NSAIDs, including Epifenac 0.1%, essentially consists of supportive measures and symptomatic treatment. Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.

Special measures such as forced diuresis, dialysis, or hemoperfusion are probably of no help in eliminating NSAIDs, including Epifenac 0.1%, due to the high protein binding and extensive metabolism.

Activated charcoal may be considered after ingestion of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) after ingestion of a potentially life-threatening overdose.

Gastro-Resistant/SR Tablets: Activated charcoal may be considered after ingestion of a potentially toxic overdose, and gastric decontamination (e.g. vomiting, gastric lavage) after ingestion of a potentially life-threatening overdose.

What should I avoid while taking Epifenac 0.1%?

Ask a doctor or pharmacist before using any cold, allergy, or other pain medicine. Medicines similar to Epifenac 0.1% are contained in many combination medicines. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid exposure to sunlight or tanning beds. Epifenac 0.1% can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Epifenac 0.1% 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.
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Cardiovascular Thrombotic Events

Clinical trials of several COX-2 selective and nonselective NSAIDs of up to three years duration have shown an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI) and stroke, which can be fatal. Based on available data, it is unclear that the risk for CV thrombotic events is similar for all NSAIDs. The relative increase in serious CV thrombotic events over baseline conferred by NSAID use appears to be similar in those with and without known CV disease or risk factors for CV disease. However, patients with known CV disease or risk factors had a higher absolute incidence of excess serious CV thrombotic events, due to their increased baseline rate. Some observational studies found that this increased risk of serious CV thrombotic events began as early as the first weeks of treatment. The increase in CV thrombotic risk has been observed most consistently at higher doses.

To minimize the potential risk for an adverse CV event in NSAID-treated patients, use the lowest effective dose for the shortest duration possible. Physicians and patients should remain alert for the development of such events, throughout the entire treatment course, even in the absence of previous CV symptoms. Patients should be informed about the symptoms of serious CV events and the steps to take if they occur.

There is no consistent evidence that concurrent use of aspirin mitigates the increased risk of serious CV thrombotic events associated with NSAID use. The concurrent use of aspirin and an NSAID, such as Epifenac 0.1%, increases the risk of serious gastrointestinal (GI) events.

Status Post Coronary Artery Bypass Graft (CABG) Surgery

Two large, controlled, clinical trials of a COX-2 selective NSAID for the treatment of pain in the first 10-14 days following CABG surgery found an increased incidence of myocardial infarction and stroke. NSAIDs are contraindicated in the setting of CABG.

Post-MI Patients

Observational studies conducted in the Danish National Registry have demonstrated that patients treated with NSAIDs in the post-MI period were at increased risk of reinfarction, CV-related death, and all-cause mortality beginning in the first week of treatment. In this same cohort, the incidence of death in the first year post-MI was 20 per 100 person years in NSAID-treated patients compared to 12 per 100 person years in non-NSAID exposed patients. Although the absolute rate of death declined somewhat after the first year post-MI, the increased relative risk of death in NSAID users persisted over at least the next four years of follow-up.

Avoid the use of Epifenac 0.1% in patients with a recent MI unless the benefits are expected to outweigh the risk of recurrent CV thrombotic events. If Epifenac 0.1% is used in patients with a recent MI, monitor patients for signs of cardiac ischemia.

Gastrointestinal Bleeding, Ulceration, And Perforation

NSAIDs, including Epifenac 0.1%, cause serious gastrointestinal (GI) adverse events including inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine, which can be fatal. These serious adverse events can occur at any time, with or without warning symptoms, in patients treated with NSAIDs. Only one in five patients, who develop a serious upper GI adverse event on NSAID therapy, is symptomatic. Upper GI ulcers, gross bleeding or perforation caused by NSAIDs occurred in approximately 1% of patients treated for 3-6 months, and in about 2%-4% of patients treated for one year. However, even short-term therapy is not without risk.

Risk Factors For GI Bleeding, Ulceration, And Perforation

Patients with a prior history of peptic ulcer disease and/or GI bleeding who use NSAIDs had a greater than 10-fold increased risk for developing a GI bleed compared to patients without these risk factors. Other factors that increase the risk of GI bleeding in patients treated with NSAIDs include longer duration of NSAID therapy, concomitant use of oral corticosteroids, aspirin, anticoagulants, or selective serotonin reuptake inhibitors (SSRIs); smoking, use of alcohol, older age, and poor general health status. Most postmarketing reports of fatal GI events occurred in elderly or debilitated patients. Additionally, patients with advanced liver disease and/or coagulopathy are at increased risk for GI bleeding.

Strategies to Minimize the GI Risks in NSAID-treated patients:

Hepatotoxicity

In clinical trials of Epifenac 0.1%- containing products, meaningful elevations (i.e., more than 3 times the ULN) of AST (SGOT) were observed in about 2% of approximately 5,700 patients at some time during Epifenac 0.1% treatment (ALT was not measured in all studies).

In a large, open-label, controlled trial of 3,700 patients treated with oral Epifenac 0.1% sodium for 2-6 months, patients were monitored first at 8 weeks and 1,200 patients were monitored again at 24 weeks. Meaningful elevations of ALT and/or AST occurred in about 4% of patients and included marked elevations (greater than 8 times the ULN) in about 1% of the 3,700 patients. In that open-label study, a higher incidence of borderline (less than 3 times the ULN), moderate (3-8 times the ULN), and marked (greater than 8 times the ULN) elevations of ALT or AST was observed in patients receiving Epifenac 0.1% when compared to other NSAIDs. Elevations in transaminases were seen more frequently in patients with osteoarthritis than in those with rheumatoid arthritis.

Almost all meaningful elevations in transaminases were detected before patients became symptomatic. Abnormal tests occurred during the first 2 months of therapy with Epifenac 0.1% in 42 of the 51 patients in all trials who developed marked transaminase elevations.

In postmarketing reports, cases of drug-induced hepatotoxicity have been reported in the first month, and in some cases, the first 2 months of therapy, but can occur at any time during treatment with Epifenac 0.1%. Postmarketing surveillance has reported cases of severe hepatic reactions, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure. Some of these reported cases resulted in fatalities or liver transplantation.

In a European retrospective population-based, case-controlled study, 10 cases of Epifenac 0.1% associated drug-induced liver injury with current use compared with non-use of Epifenac 0.1% were associated with a statistically significant 4-fold adjusted odds ratio of liver injury. In this particular study, based on an overall number of 10 cases of liver injury associated with Epifenac 0.1%, the adjusted odds ratio increased further with female gender, doses of 150 mg or more, and duration of use for more than 90 days.

Physicians should measure transaminases at baseline and periodically in patients receiving long-term therapy with Epifenac 0.1%, because severe hepatotoxicity may develop without a prodrome of distinguishing symptoms. The optimum times for making the first and subsequent transaminase measurements are not known. Based on clinical trial data and postmarketing experiences, transaminases should be monitored within 4 to 8 weeks after initiating treatment with Epifenac 0.1%. However, severe hepatic reactions can occur at any time during treatment with Epifenac 0.1%.

If abnormal liver tests persist or worsen, if clinical signs and/or symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, abdominal pain, diarrhea, dark urine, etc.), Epifenac 0.1% should be discontinued immediately.

Inform patients of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, diarrhea, pruritus, jaundice, right upper quadrant tenderness, and “flu-like” symptoms). If clinical signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g., eosinophilia, rash, etc.), discontinue Epifenac 0.1% immediately, and perform a clinical evaluation of the patient.

To minimize the potential risk for an adverse liver related event in patients treated with Epifenac 0.1%, use the lowest effective dose for the shortest duration possible. Exercise caution when prescribing Epifenac 0.1% with concomitant drugs that are known to be potentially hepatotoxic (e.g., acetaminophen, antibiotics, anti-epileptics).

Hypertension

NSAIDs, including Epifenac 0.1% can lead to new onset of hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of CV events. Patients taking angiotensin converting enzyme (ACE) inhibitors, thiazides diuretics or loop diuretics may have impaired response to these therapies when taking NSAIDs.

Monitor blood pressure (BP) during the initiation of NSAID treatment and throughout the course of therapy.

Heart Failure And Edema

The Coxib and traditional NSAID Trialists' Collaboration meta-analysis of randomized controlled trials demonstrated an approximately two-fold increase in hospitalization for heart failure in COX-2 selective-treated patients and nonselective NSAID-treated patients compared to placebo-treated patients. In a Danish National Registry study of patients with heart failure, NSAID use increased the risk of MI, hospitalization for heart failure, and death.

Additionally, fluid retention and edema have been observed in some patients treated with NSAIDs. Use of Epifenac 0.1% may blunt the CV effects of several therapeutic agents used to treat these medical conditions (e.g., diuretics, ACE inhibitors, or angiotensin receptor blockers [ARBs]).

Avoid the use of Epifenac 0.1% in patients with severe heart failure unless the benefits are expected to outweigh the risk of worsening heart failure. If Epifenac 0.1% is used in patients with severe heart failure, monitor patients for signs of worsening heart failure.

Renal Toxicity And Hyperkalemia

Renal Toxicity

Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury.

Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of an NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, dehydration, hypovolemia, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors or ARBs, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.

No information is available from controlled clinical studies regarding the use of Epifenac 0.1% in patients with advanced renal disease. The renal effects of Epifenac 0.1% may hasten the progression of renal dysfunction in patients with preexisting renal disease.

Correct volume status in dehydrated or hypovolemic patients prior to initiating Epifenac 0.1%. Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia during use of Epifenac 0.1%. Avoid the use of Epifenac 0.1% in patients with advanced renal disease unless the benefits are expected to outweigh the risk of worsening renal function. If Epifenac 0.1% is used in patients with advanced renal disease, monitor patients for signs of worsening renal function.

Hyperkalemia

Increases in serum potassium concentration, including hyperkalemia, have been reported with use of NSAIDs, even in some patients without renal impairment. In patients with normal renal function, these effects have been attributed to a hyporeninemic-hypoaldosteronism state.

Anaphylactic Reactions

Epifenac 0.1% has been associated with anaphylactic reactions in patients with and without known hypersensitivity to Epifenac 0.1% and in patients with aspirin-sensitive asthma.

Exacerbation Of Asthma Related To Aspirin Sensitivity

A subpopulation of patients with asthma may have aspirin-sensitive asthma which may include chronic rhinosinusitis complicated by nasal polyps; severe, potentially fatal bronchospasm; and/or intolerance to aspirin and other NSAIDs. Because cross-reactivity between aspirin and other NSAIDs has been reported in such aspirin-sensitive patients, Epifenac 0.1% is contraindicated in patients with this form of aspirin sensitivity. When Epifenac 0.1% is used in patients with preexisting asthma (without known aspirin sensitivity), monitor patients for changes in the signs and symptoms of asthma.

Serious Skin Reactions

NSAIDs, including Epifenac 0.1%, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Inform patients about the signs and symptoms of serious skin reactions and discontinue the use of Epifenac 0.1% at the first appearance of skin rash or any other sign of hypersensitivity. Epifenac 0.1% is contraindicated in patients with previous serious skin reactions to NSAIDs.

Premature Closure Of Fetal Ductus Arteriosus

Epifenac 0.1% may cause premature closure of the fetal ductus arteriosus Avoid use of NSAIDs, including Epifenac 0.1%, in pregnant women starting at 30 weeks of gestation (third trimester).

Hematological Toxicity

Anemia has occurred in NSAID-treated patients. This may be due to occult or gross blood loss, fluid retention, or an incompletely described effect upon erythropoiesis. If a patient treated with Epifenac 0.1% has any signs or symptoms of anemia, monitor hemoglobin or hematocrit.

NSAIDs, including Epifenac 0.1%, may increase the risk of bleeding events. Co-morbid conditions such as coagulation disorders, concomitant use of warfarin and other anticoagulants, antiplatelet agents (e.g., aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs) may increase this risk. Monitor these patients for signs of bleeding.

What should I discuss with my healthcare provider before taking Epifenac 0.1%?

Some medical conditions may interact with Epifenac 0.1% patch. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

Some MEDICINES MAY INTERACT with Epifenac 0.1% patch. Tell your health care provider if you are taking any other medicines, especially any of the following:

This may not be a complete list of all interactions that may occur. Ask your health care provider if Epifenac 0.1% patch may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Epifenac 0.1% 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.
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General: Epifenac 0.1% tablets contain lactose and therefore are not recommended for patients with rare hereditary problems of galactose intolerance, severe lactase deficiency or glucose-galactose malabsorption.

Gastrointestinal Effects: Gastrointestinal bleeding, ulceration or perforation, which can be fatal, have been reported with all nonsteroidal anti-inflammatory drugs (NSAIDs), including Epifenac 0.1%, and may occur at any time during treatment, with or without warning symptoms or a previous history of serious gastrointestinal events. They generally have more serious consequences in the elderly. If gastrointestinal bleeding or ulceration occurs in patients receiving Epifenac 0.1%, the medicinal product should be withdrawn.

As with all NSAIDs, including Epifenac 0.1%, close medical surveillance is imperative and particular caution should be exercised when prescribing Epifenac 0.1% in patients with symptoms indicative of gastrointestinal (GI) disorders or with a history suggestive of gastric or intestinal ulceration, bleeding or perforation. The risk of GI bleeding is higher with increasing NSAID doses and in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation and in the elderly.

To reduce the risk of GI toxicity in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation, and in the elderly, the treatment should be initiated and maintained at the lowest effective dose.

Combination therapy with protective agents (eg, proton pump inhibitors or misoprostol) should be considered for these patients and also for patients requiring concomitant use of medicinal products containing low-dose acetylsalicylic acid or other medicinal products likely to increase gastrointestinal risk.

Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding). Caution is recommended in patients receiving concomitant medications which could increase the risk of ulceration or bleeding eg, systemic corticosteroids, anticoagulants, anti-platelet agents or selective serotonin-reuptake inhibitors.

Close medical surveillance and caution should also be exercised in patients with ulcerative colitis or Crohn's disease, as their condition may be exacerbated.

Cardiovascular Effects: Treatment with NSAIDs including Epifenac 0.1%, particularly at high dose and in long term, may be associated with a small increased risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke).

As the cardiovascular risks of Epifenac 0.1% may increase with dose and duration of exposure, the lowest effective daily dose should be used for the shortest duration possible. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially when treatment continues for >4 weeks. Patients should be advised to remain alert for the signs and symptoms of serious arteriothrombotic events (eg, chest pain, shortness of breath, weakness, slurring of speech), which can occur without warnings. Patients should be instructed to see a physician immediately in case of such an event.

Hematologic Effects: During prolonged treatment with Epifenac 0.1%, as with other NSAIDs, monitoring of the blood count is recommended.

Like other NSAIDs, Epifenac 0.1% may temporarily inhibit platelet aggregation. Patients with defects of haemostasis should be carefully monitored.

Respiratory Effects (Preexisting Asthma): In patients with asthma, seasonal allergic rhinitis, swelling of the nasal mucosa (ie, nasal polyps), chronic obstructive pulmonary diseases or chronic infections of the respiratory tract (especially if linked to allergic rhinitis-like symptoms), reactions on NSAIDs like asthma exacerbations (so-called intolerance to analgesics/analgesics-asthma), Quincke's edema or urticaria are more frequent than in other patients. Therefore, special precaution is recommended in such patients (readiness for emergency). This is applicable as well for patients who are allergic to other substances eg, with skin reactions, pruritus or urticaria.

Hepatobiliary Effects: Close medical surveillance is required when prescribing Epifenac 0.1% to patients with impaired hepatic function, as their condition may be exacerbated.

As with other NSAIDs, including Epifenac 0.1%, values of ≥1 liver enzymes may increase. During prolonged treatment with Epifenac 0.1% (eg, in the form of tablets or suppositories), regular monitoring of hepatic function is indicated as a precautionary measure.

If abnormal liver function tests persist or worsen, if clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eg, eosinophilia, rash), Epifenac 0.1% should be discontinued. Hepatitis may occur with use of Epifenac 0.1% without prodromal symptoms. Caution is called for when using Epifenac 0.1% in patients with hepatic porphyria, since it may trigger an attack.

Skin Reactions: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs, including Epifenac 0.1%.

Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the 1st month of treatment. Epifenac 0.1% should be discontinued at the 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.

As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur in rare cases with Epifenac 0.1% without earlier exposure to the drug.

Renal Effects: As fluid retention and edema have been reported in association with NSAID therapy, including Epifenac 0.1%, particular caution is called for in patients with impaired cardiac or renal function, history of hypertension, the elderly, patients receiving concomitant treatment with diuretics or medicinal products that can significantly impact renal function and in those patients with substantial extracellular volume depletion of any cause eg, before or after major surgery. Monitoring of renal function is recommended as a precautionary measure when using Epifenac 0.1% in such cases. Discontinuation of therapy is usually followed by recovery to the pre-treatment state.

Interactions with NSAIDs: The concomitant use of Epifenac 0.1% with systemic NSAIDs including cyclooxygenase-2 selective inhibitors, should be avoided due to undesirable effects.

Masking Signs of Infections: Like other NSAIDs, Epifenac 0.1% may mask the signs and symptoms of infection due to its pharmacodynamic properties.

Impairment of Fertility: The use of Epifenac 0.1% may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Epifenac 0.1% should be considered.

Use in pregnancy: There are insufficient data on the use of Epifenac 0.1% in pregnant women. Therefore, Epifenac 0.1% should not be used during the first 2 trimesters of pregnancy unless the expected benefits to the mother outweigh the risks to the fetus. As with other NSAIDs, use of Epifenac 0.1% during the 3rd trimester of pregnancy is contraindicated owing to the possibility of uterine inertia and/or premature closure of the ductus arteriosus.

Use in lactation: Epifenac 0.1% passes into the breast milk in small amounts. Therefore, Epifenac 0.1% should not be administered during breast feeding in order to avoid undesirable effects in the infant.

Use in

Elderly: Caution is indicated in the elderly on basic medical grounds. In particular, it is recommended that the lowest effective dose be used in frail elderly patients or those with a low body weight.

Although the pharmacokinetics of Epifenac 0.1% are not impaired to any clinically relevant extent in elderly patients, Epifenac 0.1% should be used with particular caution in such patients who generally are more prone to adverse reactions.

What happens if I miss a dose of Epifenac 0.1%?

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.

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

  1. DailyMed. "DICLOFENAC EPOLAMINE: 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).
  2. DrugBank. "diclofenac". http://www.drugbank.ca/drugs/DB00586 (accessed September 17, 2018).
  3. MeSH. "Cyclooxygenase Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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