Ketorolac Tromethamine (Toradol) for Pain Relief: How It Works & What You Need to Know..

(Ketorolac Tromethamine)

Toradol ® 

30mg/ml IM/IV

 

Composition

Active ingredient: Ketorolac tromethamine (USP) ampoules containing 30mg ketorolac tromethamine in 1 ml sterile solution.

Excipient: Ethanol 10% w/v

Other Ingredients: Sodium chloride, water for injection q.s. and sodium hydroxide and/or hydrochloric acid (used for pH adjustment).

 

CLINICAL PARTICULARS

Therapeutic Indications

Toradol (ketorolac tromethamine) is indicated for the short-term management of moderate to severe acute pain, including pain following major abdominal, orthopaedic, and gynaecological operative procedures.

 

DOSAGE AND ADMINISTRATION

Dosing Considerations

Use of Toradol should be limited to the lowest effective dose for the shortest possible duration of treatment. The total duration of combined intramuscular and oral treatment should not exceed 5 days. In no case is the duration of Toradol treatment to exceed 7 days.

 

Recommended Dose and Dosage Adjustment

Adults (>18 years of age)

Dosage should be adjusted according to the severity of the pain and the response of the patient.

Parenteral: The recommended usual initial dose is 10-30mg, depending on pain severity. Subsequent dosing may be 10mg to 30mg every 4-6 hours as needed to control pain.

The administration of Toradol IM/IV should be limited to short-term therapy (not over 2 days).

The total daily dose should not exceed 120mg because the risk of toxicity appears to increase with longer use at recommended doses. The administration of continuous multiple daily doses of Toradol IM has not been extensively studied. There has been limited experience with intramuscular dosing for more than 3 days since the vast majority of patients have transferred to oral medication or no longer required analgesic therapy after this time.

Conversion from Parenteral to Oral Therapy When ketorolac tromethamine tablets are used as a follow-on therapy to parenteral ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120mg in younger adult patients or 60mg in elderly patients on the day the change of formulation is made. The total duration of combined intramuscular and oral treatment should not exceed 5 days. Elderly, Frail or Debilitated Patients.

 

Conversion from Parenteral to Oral Therapy

When ketorolac tromethamine tablets are used as a follow-on therapy to parenteral ketorolac, the total combined daily dose of ketorolac (oral + parenteral) should not exceed 120mg in younger adult patients or 60mg in elderly patients on the day the change of formulation is made. The total duration of combined intramuscular and oral treatment should not exceed 5 days.

 

Elderly, Frail, or Debilitated Patients

These patients are at increased risk of the serious consequences of adverse reactions.

Parenteral: The lower end of the dosage range is recommended. The initial dose should be 10mg. The total daily dose of Toradol in the elderly should not exceed 60mg.

Missed Dose

The missed dose should be taken as soon as remembered, and then the regular dosing schedule should be continued. Two doses of Toradol should not be taken at the same time.

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CONTRAINDICATIONS

Ketorolac Tromethamine is contraindicated in:

• Ø The perioperative settings of coronary artery bypass graft surgery (CABG).
• Ø The third trimester of pregnancy because at risk of premature closure of the ductus arteriosus and prolonged parturition.
• Ø Labour and delivery because, through its prostaglandin synthesis inhibitory effect, it may adversely affect fetal circulation and inhibit uterine musculature, thus increasing the risk of uterine hemorrhage.
• Ø Women who are breastfeeding, because of the potential for serious adverse reactions in nursing infants.
• Ø Severe uncontrolled heart failure.
• Ø Known hypersensitivity to Ketorolac Tromethamine or to other NSAIDs, including any of the components/excipients.
• Ø History of asthma, urticaria, or allergic-type reactions after taking ASA or other NSAIDs (i.e. complete or partial syndrome of ASA-intolerance rhino-sinusitis, urticaria/angioedema, nasal polyps, asthma). Fatal anaphylactic reactions have occurred in such individuals.
• Ø Active gastric/duodenal/peptic ulcer, active GI bleeding
• Ø Inflammatorybowel disease.
• Ø Cerebrovascular bleeding or other bleeding disorders.
• Ø Coagulation disorders, post-operative patients with high haemorrhagic risk or incomplete haemostasis in patients with suspected or confirmed cerebrovascular bleeding.
• Ø Immediately before any major surgery and intraoperatively when haemostasis is critical because of the increased risk of bleeding.
• Ø Severe liver impairment or active liver disease.
• Ø Moderate to severe renal impairment (serum creatinine >442 pmol/L and/or creatinine clearance <30 mL/min or 0.5 mL/sec) or deteriorating renal disease.
• Ø Known hyperkalemia.
• Ø Concurrent use with other NSAIDs due to the absence of any evidence demonstrating synergistic benefits and potential for additive side effects.
• Ø Neuraxial (epidural or intrathecal) administration.
• Ø Concomitant use with probenecid.
• Ø Concomitant use with oxpentifylline.
• Ø Children and adolescents aged less than 18 years.

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WARNINGS AND PRECAUTIONS

Potential Effects on Driving and Using Machinery Some patients may experience drowsiness, dizziness, vertigo, insomnia or depression with the use of Ketorolac Tromethamine. Therefore, patients should exercise caution in carrying out potentially hazardous activities that require alertness.

WARNING: Risk of Cardiovascular (CV) Adverse Events: Ischemic Heart Disease, Cerebrovascular Disease, Congestive Heart Failure (NYHA II-IV). Ketorolac Tromethamine is a non-steroidal anti-inflammatory drug (NSAID). Use of some NSAIDs is associated with an increased incidence of cardiovascular adverse events (such as myocardial infarction, stroke or thrombotic events) which can be fatal. The risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. Caution should be exercised in prescribing Ketorolac Tromethamine to any patient with ischemic heart disease (including but NOT limited to acute myocardial infarction, history of myocardial infarction and/or angina), cerebrovascular disease (including but NOT limited to stroke, cerebrovascular accident, transient ischemic attacks and/or amaurosis fugal) and/or congestive heart failure (NYHA II-IV).   Use of NSAIDs, such as Ketorolac Tromethamine, can promote sodium retention in a dose-dependent manner, through a renal mechanism, which can result in increased blood pressure and/or exacerbation of congestive heart failure.  Find creatinine clearance using an online creatinine clearance calculator.  Randomized clinical trials with Ketorolac Tromethamine have not been designed to detect differences in cardiovascular events in a chronic setting. Therefore, caution should be exercised when prescribing Ketorolac Tromethamine. Risk of Gastrointestinal (GI) Adverse Events   Use of NSAIDs, such as Ketorolac Tromethamine, is associated with an increased incidence of gastrointestinal adverse events (such as peptic/duodenal ulceration, perforation, obstruction and gastrointestinal bleeding).

 

General

The long-term use of Ketorolac Tromethamine is not recommended as the incidence of side-effects increases with the duration of treatment.

To minimize the potential risk for an adverse event, the lowest effective dose should be used for the shortest possible duration.

Ketorolac Tromethamine is NOT recommended for use with other NSAIDs, with the exception of low-dose ASA for cardiovascular prophylaxis, because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions.

 

Endocrine and Metabolism

Corticosteroids: Ketorolac Tromethamine is NOT a substitute for corticosteroids. It does not treat corticosteroid insufficiency. Abrupt discontinuation of corticosteroids may lead to exacerbation of corticosteroid-responsive illness.

Genitourinary

Some NSAIDs are associated with persistent urinary symptoms (bladder pain, dysuria, urinary frequency), hematuria or cystitis. Some cases have become severe on continued treatment. Should urinary symptoms occur, in the absence of an alternate explanation, treatment with Ketorolac Tromethamine must be stopped immediately to obtain recovery.

Haematologic

NSAIDs inhibiting prostaglandin biosynthesis interfere with platelet function to varying degrees; patients who may be adversely affected by such an action, such as those on anti-coagulants or suffering from hemophilia or platelet disorders should be carefully observed when Ketorolac Tromethamine is administered. Anti-coagulants: Concomitant use of NSAIDs and anticoagulants increases the risk of bleeding. Concurrent therapy of Ketorolac Tromethamine with warfarin requires close monitoring of the international normalized ratio (INR).

The concurrent use of Ketorolac Tromethamine and prophylactic, low dose heparin (2500-5000 units q12h), warfarin and dextrans may also be associated with an increased risk of bleeding. Prothrombin time should be carefully monitored in all patients receiving oral anticoagulant therapy concomitantly with ketorolac tromethamine.

Anti-platelet Effects: Ketorolac Tromethamine and other NSAIDs have no proven efficacy as anti-platelet agents and should NOT be used as a substitute for ASA or other anti-platelet agents for prophylaxis of cardiovascular thromboembolic diseases. Anti-platelet therapies (e.g. ASA) should NOT be discontinued. Concomitant administration of Ketorolac Tremethamine with low-dose ASA increases the risk of GI ulceration and associated complications.

Blood dyscrasias: Blood dyscrasias (such as neutropenia, leukopenia, thrombocytopenia, aplastic anemia and agranulocytosis) associated with the use of NSAIDs are rare, but could occur with severe consequences.

Anemia is sometimes seen in patients receiving Ketorolac Tromethamine. Patients on long-term treatment with Ketorolac Tromethamine should have their haemoglobin or haematocrit checked if they exhibit any signs or symptoms of anemia or blood loss.

Hepatic / Biliary / Pancreatic

As with other NSAIDs, borderline elevations of one or more liver enzyme tests (AST, ALT, alkaline phosphatase) may occur in up to 15% of patients.

Severe hepatic reactions, including jaundice and cases of fatal hepatitis, liver necrosis, and hepatic failure, some of them with fatal outcomes, have been reported with NSAIDs.

Although such reactions are rare, if abnormal liver tests persist or worsen, if clinical signs and symptoms consistent with liver disease develop (e.g. jaundice), or if systemic manifestations occur (e.g.eosinophilia, associated with rash, etc.), ketorolac tromethamine should be discontinued.

Caution should be observed if Ketorolac Tromethamine is to be used in patients with a history of liver disease.

 

Hypersensitivity Reactions

Anaphylactic Reactions: As with NSAIDs in general, anaphylactic reactions have occurred in patients without known prior exposure to Ketorolac Tromethamine. In post-marketing experience, rare cases of anaphylactic/anaphylaxis reactions and angioedema have been reported in patients receiving Ketorolac Tromethamine.

ASA-Intolerance: Ketorolac Tromethamine should NOT be given to patients with complete or partial syndrome of ASA-intolerance (rhino sinusitis, urticaria/angioedema, nasal polyps, asthma) in whom asthma, anaphylaxis, urticaria/angioedema, rhinitis or other allergic manifestations are precipitated by ASA or other NSAIDs. Fatal anaphylactic reactions have occurred in such individuals.

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Infection

Aseptic Meningitis: Rarely, with some NSAIDs, the symptoms of aseptic meningitis (stiff neck, severe headaches, nausea and vomiting, fever or clouding of consciousness) have been observed. Patients with autoimmune disorders (systemic lupus erythematosus, mixed connective tissue diseases, etc.) seem to be pre-disposed.

Neurologic

Some patients may experience drowsiness, dizziness, blurred vision, vertigo, tinnitus, hearing loss, insomnia or depression with the use of Ketorolac Tromethamine. If patients experience such adverse reaction(s), they should exercise caution in carrying out activities that require alertness.

Ophthalmologic

Blurred and/or diminished vision has been reported with the use of NSAIDs. If such symptoms develop, Ketorolac Tromethamine should be discontinued and an ophthalmologic examination performed.

 

Renal

Renal insufficiency due to NSAID use is seen in patients with pre-renal conditions leading to a reduction in renal blood flow or blood volume. Under these circumstances, renal prostaglandins help maintain renal perfusion and glomerular filtration rate (GFR). In these patients, administration of an NSAID may cause a reduction in prostaglandin synthesis leading to impaired renal function. Serious or life-threatening renal failure has been reported in patients with normal or impaired renal function after short term therapy with NSAIDs. Discontinuation of NSAIDs is usually followed by recovery to the pre-treatment state.

 Find creatinine clearance using an online creatinine clearance calculator. 

Fluid and Electrolyte Balance:

 Use of Ketorolac Tromethamine, can promote sodium retention in a dose-dependent manner, which can lead to fluid retention and edema, and consequences of increased blood pressure, edema, and exacerbation of congestive heart failure.

Caution should be exercised in prescribing Ketorolac Tromethamine in patients with a history of congestive heart failure, compromised cardiac function, cardiac decompensation, hypertension, increased age or other conditions predisposing to fluid retention.

Use of Ketorolac Tromethamine, can increase the risk of hyperkalemia, especially in patients with diabetes mellitus, renal failure, increased age, or those receiving concomitant therapy with adrenergic blockers, angiotensin-converting enzyme inhibitors, angiotensin-II receptor antagonists, cyclosporine, or some diuretics.

 

Respiratory

ASA-induced asthma is an uncommon but very important indication of ASA and NSAID sensitivity. It occurs more frequently in patients with asthma who have nasal polyps. Sexual Function/Reproduction/Fertility

The use of Ketorolac Tromethamine, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. Therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of Ketorolac Tromethamine should be considered.

Skin

In rare cases, serious skin readrans, some of them fatal, such as Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis and erythema multiform have been associated with the use of some NSAIDs. These reactions are potentially life threatening but may be reversible if the causative agent is discontinued and appropriate treatment instituted.

 

Special Populations:

Pregnant Women

Ketorolac Tromethamine is CONTRAINDICATED for use during the third trimester of pregnancy because of risk of premature closure of the ductus arteriosus and the potential to prolong parturition.

Caution should be exercised in prescribing Ketorolac Tromethamine during the first and second trimesters of pregnancy.

Ketorolac Tromethamine is not recommended in labour and delivery because, through their prostaglandin synthesis inhibitory effect, they may adversely affect fetal circulation and inhibit uterine contractions, thus increasing the risk of uterine hemorrhage.

Geriatrics

Patients older than 65 years and frail or debilitated patients are more susceptible to a variety of adverse reactions from NSAIDs Post-marketing experience with Ketorolac Tromethamine suggests that there may be a greater risk of gastrointestinal ulcerations, bleeding, and perforation in in the elderly and most spontaneous.

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DRUG-DRUG INTERACTIONS

Acetylsalicylic acid (ASA) or other NSAIDs The use of Ketorolac Tromethamine for analgesic and/or anti-inflammatory effects is usually contraindicated because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions.

Anti-hypertensive: Combinations of ACE inhibitors, Angiotensin-Il antagonists or diuretics with NSAIDs might have an increased risk for acute renal failure and hyperkalemia. Blood pressure and renal function (including electrolytes) should be monitored more closely in this situation, as occasionally there can be a substantial increase in blood pressure.

Antiplatelet Agents (including ASA): When antiplatelet agents are combined with ketorolac tromethamine, there is an increased risk of bleeding via inhibition of platelet function.

Digoxin: Concomitant administration of an NSAID with digoxin can result in an increase in digoxin concentrations which may result in digitalis toxicity. Increased monitoring and dosage adjustments of digitalis glycosides may be necessary during and following concurrent NSAID therapy. Ketorolac tromethamine does not alter digoxin protein binding.

Diuretics: Ketorolac tromethamine reduces the diuretic response to furosemide by approximately 20% in normovolemic subjects, so particular care should be taken in patients with cardiac decompensation.

Glucocorticoids: Some studies have shown that the concomitant use of NSAIDs and oral glucocorticoids increases the risk of GI adverse events such as ulceration and bleeding.

Lithium: Monitoring of plasma lithium concentrations is advised when stopping or starting a NSAID, as increased lithium concentrations can occur. The effect of ketorolac Tromethamine on lithium plasma levels has not been studied. Cases of increased lithium plasma concentrations during therapy with Ketorolac Tromethamine have been reported.

Methotrexate: Caution is advised in the concomitant administration of methotrexate and NSAIDs, as this has been reported to reduce the clearance of methotrexate, thus enhancing its toxicity.

Oxpentifylline: When Ketorolac Tromethamine is administered concurrently with oxpentifylline, there is an increased tendency to bleeding. The concomitant use of Ketorolac Tromethamine and oxpentifylline is contraindicated.

Probenacid: Concomitant administration of ketorolac Tromethamine and probenacid results in the decreased clearance and volume of distribution of ketorolac and a significant increase in ketorolac plasma levels (approximately 3-fold increase) and terminal half-life (approximately 2-fold increase). The concomitant use of Ketorolac Tromethamine and probenacid is contraindicated. Selective Serotonin Reuptake Inhibitors (SSRis): Concomitant administration of NSAIDs and SSRIs may increase the risk of gastrointestinal ulceration and bleeding.

Less Common Clinical Trial Adverse Drug Reactions (< 1%) Nervous system: Insomnia, increased dry mouth, abnormal dreams, anxiety, depression, paraesthesia, nervousness, paranoid reaction, speech disorder, euphoria, libido increased, excessive thirst, inability to concentrate, stimulation.

Digestive system: Flatulence, anorexia, constipation, diarrhea, dyspepsia, gastrointestinal fullness, gastrointestinal haemorrhage, gastrointestinal pain, melena, sore throat. liver function abnormalities, rectal bleeding, stomatitis.

 

Cardiovascular system: Hypertension, chest pain, tachycardia. haemorrhage, palpitation, pulmonary embolus, syncope. ventricular tachycardia, pallor, flushing.

Injection site: Injection site reaction.

Body as a Whole: Asthenia, fever, back pain, chills, pain, neck pain.

Special senses: Taste perversion, tinnitus, blurred vision. diplopia, retinal haemorrhage.

Muscular-skeletal system: Myalgia, twitching.

Respiratory system: Asthma, cough increased, dyspnea, epistaxis, hiccup, rhinitis.

Skin and appendages: Pruritus, rash, subcutaneous hematoma. skin disorder.

Urogenital system: Dysuria, urinary retention, oliguria, increased urinary frequency, vaginitis.

Metabolic/nutritional disorders: Edema, hypokalemia, hypovolemia.

Hematologic and lymphatic system: Anemia, coagulation disorder, purpura.

 

Post-Market Adverse Drug Reactions

Renal Events: Acute renal failure, flank pain with or without haematuria and/or azotemia, nephritis, hyponatremia, hyperkalemia, hemolytic uremic syndrome, urinary retention.

Hypersensitivity Reactions: Bronchospasm, laryngeal edema, asthma, hypotension, flushing, rash, anaphylaxis, angioedema and anaphylactoid reactions. Such reactions have occurred in patients with no prior history of hypersensitivity. Gastrointestinal Events: Gastrointestinal hemorrhage, peptic ulceration, gastrointestinal perforation, pancreatitis, melena, esophagitis, hematemesis.

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Hematologic Events: Postoperative wound haemorrhage, rarely requiring blood transfusion, thrombocytopenia, epistaxis, leukopenia, hematomata, increased bleeding time.

Central Nervous System: Convulsions, abnormal dreams. hallucinations, hyperkinesia, hearing loss, aseptic meningitis, extrapyramidal symptoms, psychotic reactions.

Hepatic Events: Hepatitis, liver failure, cholestatic jaundice. Cardiovascular: Pulmonary edema, hypotension, flushing. bradycardia. Reproductive, female: Infertility.

Dermatology: Lyell's syndrome, Stevens-Johnson syndrome, exfoliative dermatitis, maculopapular rash, urticarial.

Body as a Whole: Infection.

Urogenital: Interstitial nephritis, nephrotic syndrome, raised serum urea and creatinine………………………….

 

reactions have been reported with therapeutic ingestion of NHA and may occur following an overdose, Treatment

Patients should be managed by symptomatic and supportive care following overdose. There are no specific antidotes. Dialysis does not significantly clear ketorolac from the bloodstream

 

CLINICAL PHARMACOLOGY

Mechanism of Action:

Ketorolac Tromethamine is a non-steroidal anti-inflammatory drug (NSAID) that exhibits analgesic activity mediated by peripheral effects. The mechanisin of action of ketorolac, like that of other NSAIDs, is not completely understood, but is believed to be related to prostaglandin synthetase inhibition.

 Pharmacokinetics:

The Pharmacokineties is linear following single and multiple dosing Steady state plasma levels are attained after one day of QTD. dosing

The parenteral administration of Ketorolac Tromethamine has not been demonstrated to affect the hemodynamics of anaesthetized patients.

Absorption: Ketorolac tromethamine was rapidly (Tues ranged from 0.25 to 1.5 hours) and completely absorbed after oral and IM dose (99%),

Distribution: The volume of distribution of ketorolac was estimated following intravenous dosing and it averaged 0.15 L/k Ketorolac was highly protein bound (99.2%). Binding was concentration independent.

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Clearance and Half-life: The pharmacokineties of ketorolac in man following single or multiple intramuscular doses are linear. Steady state plasma levels are achieved after dosing every 6 hours for one day. The plasma half-life averaged 6.0 hours. Total plasma clearance averaged 0.35 mL/min/kg in humans. Metabolism: Ketorolac is largely metabolized in the liver. The major metabolic path of ketorolac in humans is glucuronic acid conjugation. P-hydroxylation is an additional minor pathway. The metabolism and excretion patterns of ketorolac and its metabolites were similar following po, iv. and im. dosing in the species studied. Ketorolac and its metabolites were excreted predominantly in the urine averaged 92% in humans.

 

Elimination/Excretion: The primary route of excretion of ketorolac tromethamine and its metabolites (conjugates and the p-hydroxy metabolite) is in the urine (91.4%) with the remainder (6.1%) being excreted in the feces Special Populations and Conditions.

Geriatrics (265 years of age): The terminal plasma half-life of ketorolac is prolonged compared to young healthy volunteers to an average of 7 hours (ranging from 4.3 to 8.6 hours). The total plasma clearance may be reduced compared to young healthy volunteers, on average to 0.019 L/h/kg.

Hepatic Insufficiency: Patients with impaired hepatic function do not have any clinically important changes in ketorolac pharmacokinetics, although there is a statistically significant prolongation of Tmas and terminal phase half-life compared to young healthy volunteers.

Renal Insufficiency: Elimination of ketorolac is decreased in patients with renal impairment as reflected by a prolonged plasma half-life and reduced total plasma clearance when compared to young healthy subjects. The rate of elimination is reduced roughly in proportion to the degree of renal impairment except for patients who are severely really impaired, in whom there is higher plasma clearance of ketorolac than estimated from the degree of renal impairment alone.

 

PHARMACEUTICAL PARTICULARS

Special Instructions for Use, Handling and Disposal Incompatibilities

 

Ketorolac Tromethamine Solution for injection should not be mixed in a small volume (e.g. in a syringe) with morphine sulphate, pethidine hydrochloride, promethazine hydrochloride or hydroxyzine hydrochloride; this will result in precipitation of ketorolac from solution. Ketorolne Tromethamine solution for injection is compatible with normal saline, 5% dextrose, Ringer's, Lactated Ringer's or Plasmalyte solutions. When mixed together in iv. solutions contained in standard bottles or bag administration sets, it is compatible with aminophylline, lidocaine hydrochloride, morphine sulphate, meperidine hydrochloride, dopamine hydrochloride, regular human insulin and heparin sodium.

 

Stability

Toradol must not be used after the expiry date (EXP) shown on the pack. Toradol ampoules must not be used if particulate matter is present in the solution,

 

Instructions:

Discard any portion of the contents remaining after use.

Do not use if particulate matter is present. Do not store above 30°C. Protect from light and heat. Keep all medicines out of the reach of children. To be sold on prescription of a registered medical practitioner only.

 

Reference:

1. KETOROLAC TROMETHAMINE- ketorolac tromethamine injection, solution 
Hospira, Inc.

 2. Ketorolac (Toradol) - Uses, Side Effects, and More

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