Nicarlol Plus tablets 5mg/12.5mg Agimexpharm treat hypertension (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Nebivolol, hydrochlorothiazide
Ingredient
| Composition information | Content |
| Nebivolol | 5mg |
| Hydrochlorothiazide | 12.5mg |
Uses
indications
Nicarlol Plus V-5/12.5mg drug indicated for hypertension treatment.
Pharmacokology
involves nebivolol
Nebivolol is a racemic mixture of two forms of SRRR-nebivolol (or D-nebivolol) and RSSS-Nebivolol (or L-nebolol).
Medicine combines both pharmacological effects:
Nebivolol is a selective and competitive beta receptor blocker: This effect is due to the isomer SRRR-Nebivolol (D-nebivolol).
The drug has light vasodilators due to interaction with l-arginin/nitric oxide on the way.
related to hydrochlorothiazid
hydrochlorothiazid increases the excretion of sodium chloride and waters water due to the mechanism of inhibiting the reabsorption of sodium and chlorine ions in the distance. The excretion of other electrolytes also increases, especially potassium and magnesi, and calcium decreases.
hydrochlorothiazid also reduces the activity of carbon dioxide, so it increases the secretion of bicarbonate but this effect is often weak compared to the ion secretion effect and does not significantly change the urine pH.
Thiazid diuretics may also reduce the speed of glomerular filtration. Thiazids have a moderate diuretic effect, because about 90% of sodium ions have been reabsorbed before arriving in the distance is the main position of the drug.
hydrochlorothiazid has the effect of lowering blood pressure, firstly due to a decrease in plasma volume and extracellular fluid related to sodium cards.
Then during the use of the drug, the effect of lowering blood pressure depends on the decrease in peripheral resistance, through the gradual adaptation of blood vessels from the reduction of Na+ionic concentration. Therefore, the hypotension effect of hydrochlorothiazid is shown slowly after 1-2 weeks, while the diuretic effect occurs quickly and can be seen right after a few hours. Hydrochlorothiazid increases the effects of other antihypertensive drugs.
Combining Nebivolol 5 mg and hydrochlorothiazid 12.5 mg in Nicarlol Plus 5 mg/ 12.5 mg, increasing the hypotension effect of the drug.
Dynamic pharmacokinetics
related to nebivolol
absorption:
Both Nebivolol isomer is quickly absorbed after drinking. Nebivolol's absorption is not affected by food, so Nebivolol can be used regardless of meals.
Nebivolol's oral bio -roamed on average 12% in fast -changing and almost completely modified people.In a stable state and with the same dose level, the peak concentration of Nebivolol's plasma does not change about 23 times higher than that of poor people than those who are stronger than those.
When the drug does not change plus the active metabolites are considered, the difference in the peak concentration in plasma from 1.3 to 1.4 times. Due to the change in the metabolic rate, the dose of Nebivolol must always be adjusted according to the requirements of each patient: Poor people need to do less doses.
A plasma concentration ratio at the dose between 1 and 30 mg. Nebivolol's pharmacokinetics are not affected by age.
Distribution:
Stable plasma levels in most subjects (fast metabolic) achieved within 24 hours for nebivolol and within a few days for hydroxyl metabolites. In plasma, both nebivolol isomers are largely combined with albumin. Plasma protein bonds are 98.1% for SRRR-Nebivolol and 97.9% for RSSS-Nebivolol.
Metabolism:
Nebivolol is metabolized, partly forming a active hydroxyl metabolic substance. Nebivolol is metabolized through the saturated and aromatic rings, reducing alkyl in N-and glucuronicization, in addition to forming glucuronids of hydroxyl metabolites. The metabolism of nebivolol by hydroxylation of aromatic rings depends on the polymorphic oxidation properties with genetic properties dependent CYP2D6.
The average Nebivolol's oral bioavailability is 12% in fast metabolic and almost entirely in slow metabolic people.
Era:
Because there are many different levels of metabolism, Nebivolol's dose should always be adjusted according to the response of each patient: Low metabolic people need lower doses. In fast metabolic people, the sale time of nebivolol isomers average is 10 hours.
In people with slow metabolic, 3 to 5 times longer. In fast metabolic people, the sale time of hydroxyl metabolites of both types of isomers is 24 hours and double the time in slow metabolic people.
A week after taking the drug, 38% of the dose is excreted in the urine and 48% in feces. The excretion in urine in the form of unchanged Nebivolol is less than 0.5% of the dose.
related to hydrochlorothiazid
absorption:
Hydroclorothiazid is well absorbed after oral (65 to 75%). The concentration in plasma is linearly related to the dose. The absorption of hydrochlorothiazid depends on the time of transportation through the intestine, increasing when the shipping time through the intestine is slow, for example when used at a meal.
When monitoring plasma concentrations for at least 24 hours, the semi -discharged time in plasma varies from 5.6 to 14.8 hours and the peak concentration in plasma is achieved after taking the drug for 1 and 5 hours.
Distribution:
About 68% hydrochlorothiazid associated with protein in plasma and the expression distribution volume from 0.83-1.14 l/kg. Hydrochlorothiazid passes through the placenta but does not go through the blood-flabby barrier.
Metabolism:
Hydroclorothiazid is metabolized very little. Almost all hydrochlorothiazids are excreted in the urine in the form of unchanged.
Era:
hydrochlorothiazid is excreted mainly through the kidneys. More than 95% of hydrochlorothiazid is found in the form of unchanged urine within 3-6 hours after a dose of oral. In patients with renal disease, the concentration of hydrochlorothiazid in plasma increases and the semi -waste time is prolonged.
Before taking Nicarlol Plus tablets 5mg/12.5mg Agimexpharm treat hypertension (3 blisters x 10 tablets)
How to use
Nicarlol Plus V-5/12.5mg drug used orally. Drink at a certain time of the day, can be taken at meals.
Dosage
Adults: 1 tablet/day.
Patients with impaired renal function: Recommendation should not be used in patients with severe renal impairment (clearing creatinine
Patients with impaired liver function: recommendations should not be used
Elderly: Experience in treatment for a group of 75 years of age is limited. So be cautious and patients must be closely monitored.
Children and adolescents: The effectiveness and safety of drugs for children and teenagers under 18 years of age have not been determined, so it is not recommended to use drugs for this group of patients.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.
What to do when using overdose?
Overdose manifestations: Nebivolol overdose symptoms are similar to beta blockers: slow heart rate, hypotension, bronchospasm and acute heart failure.
Management:
In case of overdose or hypersensitivity to the drug, the patient should be taken to medical facilities for special treatment and care. Blood sugar should be checked. It is possible to prevent the absorption of the remaining medication still present in the gastrointestinal tract by gastrointestinal and activated carbon and laxative. Need artificial respiration.
Grady heart rate or excessive sympathetic reaction should be treated using atropine or methylatropin.
Hypotension and shock should be treated with plasma or plasma substitutes and if necessary to use catecholamine.
The effect of beta blockers can be reduced by slow intravenous injection isoprenalin hydrochloride, starting at a dose of about 5µg/min, or with dobutamin, starting at a dose of 2.5 µg/min, until the desired effect. In persistent cases, using isoprenalin can be combined with dopamine.
If there is still no desired effect, the glucagon 50-100 intravenous injection can be injured µg/kg. If necessary, intravenous injection is repeated within an hour, followed by glucagon 70 µg/kg/hour. In the field of heart rate, too slow resistance to treatment can use an additional heart rate air conditioner.
Related to hydrochlorothiazide:
Extremely manifestation: The expression of an overdose is mainly water and electrolyte disorders due to a lot of urinary tract.
Management:
Gastrointestinal lavage when using medication, using activated carbon.
Anti -alkaline blood: Use ammonium chloride unless the person has liver disease.
Quickly compensate for the amount of water and electrolytes lost.
can separate peritoneal to adjust water and electrolyte balance. In the case of hypotension without responding to the above interventions, using 4 mg/liter norepinephrin 4 mg/liter intravenously or dopamine in the initial dose of 5 micrograms/kg/min.
In an emergency, call the 115 emergency center immediately or go to the nearest local health station.
What to do when you forget 1 dose? However, if the time to relax with the next dose is too short, skip the dose and continue the calendar of the drug. Do not use double dose to compensate for missed dose.
Side Effects
Unwanted effects (ADR) when using Nicarlol Plus V-5/12.5mg that you may encounter:
involves nebivolol
Unwanted effects are recorded separately according to high blood pressure and chronic heart failure because of the difference in the accompanying pathological condition.
High blood pressure:
In most cases the unwanted effects from light to medium have been reported, presented in the following table, classified by body systems and frequency order.
(1/100 ≤
ADR
(1/1000 ≤
ADR
(ADR
. 000)
Mental disorders
Chronic heart failure:
Data on unwanted effects for patients with chronic heart failure obtained from a clinical trial compared to the placebo over 1067 patients using Nebivolol and 1061 patients to use placebo.
In this study, a total of 449 patients using Nebivolol (42.1%) experience unwanted effects that may be related to drug use compared to 334 patients using placebo (31.5%).
The most unwanted effects are reported in patients using Nebivolol are slow and dizziness, both symptoms occur in about 11% of patients. The frequency corresponding to the placebo group is about 2% and 7%.
The ratio of unwanted effects is reported below (capable of drug use), which is considered specially related to the treatment of chronic heart failure.
The worse heart failure occurs in 5.8% of patients using Nebivolol compared to 5.2% of patients with placebo.
Hypotension is reported in 2.1% of patients using Nebivolol compared to 1.0% of patients using placebo.
Integrated drugs are reported in 1.6% of patients using Nebivolol compared to 0.8% of patients with placebo.
Atrial-level 1-level bloc occurs in 1.4% of patients using nebivolol compared to 0.9% of patients using placebo.
The lower limb is reported in 1.0% of patients using nebivolol compared to 0.2% of the placebo.related to hydrochlorothiazid
hydrochlorothiazid may cause excessive potassium loss. This effect depends on the dose and can be reduced when low doses (12.5 mg/day), the best dose for hypertension treatment, while minimizing harmful reactions.
Common, ADR> 1/100
Rare, ADR
Instructions on how to handle ADR:
Dehydration and electrolytes can cause hypotension, alkaline metabolism, hypokalemia, sodium blood. It is necessary to check the electrolytes and compensate for the amount of water and electrolytes.
People with coronary artery disease, ischemia heart disease are very sensitive to potassium loss and risk of arrhythmia. Serum potassium concentration below 30 MEQ/liter is at high risk. These patients should be carefully checked for electrolyte balance and need potassium compensation. Using low doses of diuretics is important to limit this harm.
Patients who are treating digitalis are at risk of digitalis poisoning when potassium in the blood decreases. Potassium addition needs to use diuretics.
Patients who are treating Quinidine are at risk of arrhythmia when reducing potassium. Need to check the electrolyte and add potassium. It is also necessary to be so cautious for patients who are being treated with any drugs that affect the diarrhea, such as phenothiazin and three -round antidepressants.
Notify the doctor the unwanted side effects when using the drug.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Nicarlol Plus V-5/12.5mg contraindicated drug in the following cases:
Be cautious when using
involving Nebivolol
Anesthesia:
Maintain the treatment with beta blockers reduces the risk of arrhythmia during the process of induction preparation for anesthesia and intubation. If you have to stop beta blockers to prepare surgery, it should be stopped at least 24 hours in advance.
Caution should be monitored for some anesthetic that can cause myocardial failure. Patients are protected against sympathetic neurological reactions by intravenous intravenous injection.
Cardiovascular:
Normally, beta-adrenergic blockers should not be used for patients with congestive heart failure, unexplained, unless the patient's condition is stable.
In patients with ischemic disease, treatment with beta blockers should stop from (1-2 weeks). If needed, replacement treatment should start the same time to prevent acadive batch of angina.
Beta-adrenergic blockers can cause slow heart rate: If the circuit rate drops below 50-55 beats/minute at rest and/or patients with signs related to bradycardia, dose reduction.
Should be cautious when taking Beta-commenergic blockers:
In patients with peripheral circulatory disorders (Raynaud's disease or syndrome, regression pain) because they may worsen these disorders.
In patients with heart -level 1 -hearted heart, due to the negative effect of beta blockers during transmission.
In patients with Prinzmetal angina due to the indirect alpha receptor air resistance that causes coronary arteries, beta-adrenergic blockers can increase the number of times and the time of angina.
Endocrine metabolism:
Nebivolol does not affect glucose in diabetics. However, be cautious for diabetics, because Nebivolol can cover some symptoms of hypoglycemia (tachycardia, brushing chest drum).
beta-adrenergic blockers can cover symptoms of tachycardia in patients with hyperthyroidism. Sudden stopping the drug can exacerbate the symptoms.
Other:This drug contains lactose. Patients with rare genetic metabolic disorders in galactose tolerance, lactase deficiency lactase or Glucose-Galactose absorption disorders should not use this drug.
Be careful when treating patients with a history of psoriasis with beta inhibitors because these drugs can cause increased sensitivity to allergens and worsen hypersensitivity reactions.
It is necessary to control regularly at the beginning of the treatment of chronic heart failure with Nebivolol. Do not suddenly stop treatment unless there is clear indications.
related to hydrochlorothiazid
kidney failure:
The whole benefit from treatment with thiazid diuretics can only be achieved if the kidney function is not changed. In patients with kidney failure, thiazid diuretics may increase blood nitrogen.
The accumulated effects of this substance can occur in patients with impaired renal function. If the renal failure progresses clearly, such as the nitrogen increase from protein, it is necessary to carefully reassess the treatment, and consider the discontinuation of diuretics.
Effects on metabolism and endocrine:
Treatment with thiazid derivatives may change glucose tolerance. It may be necessary to adjust insulin dosage or hypoglycemic oral medications. Potential diabetes can appear in thiazid therapy.
Treatment of thiazid diuretics may be related to increased cholesterol and triglyceride levels. In some patients, thiazid therapy can reduce uric acid secretion through the renal tubules, increase blood uric acid and / or gout attacks.
Electrolyte imbalance:
Like all patients treated with diuretics, checking electrolytes in serum should be performed regularly.
Thiazid derivatives, including hydrochlorothiazid, can cause imbalance of fluid-solving (especially hypokalemia, blood sodium hypoglycemia and metabolic alkali infections due to hypothermia). Warning signs of imbalance of fluid - electrolytes are dry mouth, thirst, weakness, sleep, sleep, restlessness, muscle pain, cramps, muscle fatigue, lower blood pressure, urine, tachycardia and digestive disorders such as nausea or vomiting.
The risk of hypokalemia increases in patients with cirrhosis, in patients with urethra quickly, in patients who are receiving insufficient electrolyte diet and in patients treated simultaneously with corticosteroids or ACTH.
Patients with long, congenital or drug -based QT syndrome, especially high risk in the case of hypokalemia. Hypotension increases the toxicity of the hearts of digitalis glycosides and the risk of arrhythmia. Monitoring more frequent blood potassium is indicated for patients at risk of hypokalemia, starting within a week after the beginning of treatment.
Demated blood sodium that may occur in patients with edema in hot weather. Surrated sodium is generally mild and no need for treatment.
Thiazid may reduce calcium secretion and increase serum and mildly without disorders for calcium metabolism. Disclosure hypercalcemia may be a sign of hyperplasia hyperplasia. Thiazid medications must be stopped before conducting adjacent function tests.
Thiazid diuretics may increase the secretion of magnesi in the urine that can lead to reduced magnesium in the blood.
lupus erythematosus:
There have been reports on treatment for thiazid diuretics that increase or activate systemic lupus erythematosus.
Anti-down test (anti-stimulant):
hydrochlorothiazid contained in this drug can lead to positive results in anti -stimulant tests.
Other:Hypersensitivity reactions may occur in patients with or without a history of allergies or bronchial asthma. Light -sensitive reactions in some rare cases have been reported to thiazid diuretics.
If such a reaction occurs during treatment, treatment should be stopped. If the treatment is necessary, the contact areas must be protected to avoid sunlight or artificial UVA light.
iodine associated with protein:
Thiazid may reduce the amount of iodine associated with serum protein without signs of thyroid dysfunction.
This product contains lactose. Patients with rare genetic problems in tolerance Galactose, Lapp Lactase deficiency or Glucose-Galactose should not be used.
Used for pregnant and lactating women
Pregnant women:
There is no adequate data for the use of nebivolol/hydrochlorothiazid in pregnant women. Animal studies with each component are not enough to determine the impact of the combination of nebivolol and hydrochlorothiazide on reproduction.
nebivolol:
Due to the lack of data, the possible harm of Nebivolol's use in pregnant women cannot be set. However, Nebivolol has a pharmacological effect that can cause harm to pregnant women and/ or fetus/ infant. In general, beta blockers reduce the amount of blood through the placenta; Related to developmental delay, death in the uterus, miscarriage or premature birth.
Side effects (such as hypoglycemia, slow heart rate) can occur in fetus and infant. If the treatment with beta blockers is necessary, it is better to use Beta-1 inhibitors.
Do not use nebivolol during pregnancy unless necessary. If treated with nebivolol is considered necessary, blood flow to the uterus of the placenta and the growth of the fetus should be monitored.
In case of harmful effects on pregnant women or fetus should consider replacement treatment. Babies must be closely monitored. Symptoms of hypoglycemia and slow heart rate often occur in the first 3 days.
hydrochlorothiazid:
Data on the use of hydrochlorothiazid during pregnancy, especially in the first 3 months, is limited. Inadequate animal studies.
hydrochlorothiazid through the placenta fence. Based on the pharmacological mechanism for the activity of hydrochlorothiazid, using it in the middle 3 months and the last 3 months of pregnancy can reduce the amount of blood to the fetus-fetal fetus and can affect the fetus and infants such as jaundice, electrolyte balance disorders and thrombocytopenia.
Do not use hydrochlorothiazid to treat fetal edema, pregnancy hypertension or pre -eclampsia due to the risk of hypoglycemia and hematuria to the placenta, without beneficial effects in the evolution of the disease.
Do not use hydrochlorothiazid to treat the treatment of arterial hypertension in pregnant women except in rare cases at that time other treatment cannot be applied.
breastfeeding women:
It is not known whether Nebivolol will be excreted in breast milk or not. Animal research shows that Nebivolol is excreted in breast milk. Most beta blockers, especially craving compounds like Nebivolol and its metabolites are into breast milk at a different degree.
hydrochlorothiazid is excreted in breast milk in small amounts. High doses of high -dose thiazid diuretics can inhibit milk secretion. Nebivolol/hydrochlorothiazide should not be used during breastfeeding. If you need to use nebivolol/hydrochlorothiazid during breastfeeding, the dose should be as low as possible.
The impact of the drug on the ability to drive and operate machinery
because the drug causes headaches, dizziness is careful to drive and operate machinery when using the drug.
Drug interaction
related to nebivolol
Pharmacological interaction:
The following interactions are applied to the beta blocker group:
Do not coordinate:
Group I anti-arrhyths (quinidin, hydroquinidin, cibenzolin, flecainid, disopyramid, lidocaine, mexiletin, propafenon): increase the impact on the atrial-transmission time and increase negative mechanical impact.
Calcium channel blockers belong to the Verapamil/Diltiazem group: negative effects on the contraction and atrial transmission. Verapamil intravenous injection in patients being treated with beta blockers can lead to excessive hypotension and atrial hypotension.
Hematoplasty drugs act on the central (Clonidin, Guanfacin, Moxonidin, Methyldopa, Rilmenidin): Concentrated use with antihypertensive drugs acting on the central can worsen heart failure due to decreased central sympathetic nerves (reduced heart rate and heart power, vasodilation). Stopping the drug suddenly, especially if it previously stopped using beta blockers, may increase the risk of ‘‘ hypertension backward ’.
Caution when coordinating:
Anti-arrhythmic drugs Group III (Amiodaron): Increases the impact on the Time of Turkish.
Halogen derivative anesthesia: Concomitance of beta and anesthetic blockers can reduce reflected fast heart rate and increase the risk of hypotension. In principle, avoid sudden stopping of beta blockers. Notify anesthesia staff when patients are taking Nebivolol.
insulin and oral medication for diabetes treatment: although Nebivolol does not affect the blood glucose concentration in the blood, simultaneously covers a few symptoms of hypoglycemia (fast heart rate, chest drum).
Baclofen (muscle relaxants), amifostin (cancer support drugs): Concomitant use with antihypertensive drugs capable of increasing hypotension. Therefore, the dosage of antihypertensive drugs should be adjusted appropriately.
Note when coordinating:
Digitalis glycosid: simultaneous use may increase the time of transmission. Clinical trials with Nebivolol did not see any clinical evidence of interaction. Nebivolol does not affect Digoxin's pharmacokinetics.
Calcium blockers of dihydropyridin group (amlodipin, felodipine, lacidipin, nifedipine, nicardipine, nimodipine, nitrendipine): simultaneous use may increase the risk of lowering blood pressure and do not eliminate the risk of impaired blood pumping of the heart failure.
Sedative, antidepressants (3 rounds, barbiturat and phenothiazin): Simultaneous use may increase the hypotension effect of beta blockers (force impact).
Non -steroid anti -inflammatory drugs (NSAID): does not affect the effectiveness of blood pressure loss of Nebivolol.
Seed-like drugs: Simultaneous use can neutralize the effects of beta-adrenergic blockers. Beta-commenergic blockers can lead to non-anti-alpha-adrenergic activity of sympathetic drugs with both effects of alpha and beta-adrenergic (risk of hypertension, severe heart rhythms and heart heart blocks).
pharmacokinetic interaction:
Due to the metabolic mechanism of Nebivolol related to isenzyme CYP2D6, simultaneous use with these enamel inhibitors, especially paroxetin, fluoxetin, thioridazin and quinidine can increase the plasma concentration of Nebivolol in combination with increasing the risk of too slow heart rate and other disadvantaged effects.
Using nebivolol in combination with cimetidine increases the concentration of nebivolol in plasma but does not change the clinical effect.
Used in combination with ranitidin does not affect the pharmacokinetics of Nebivolol as long as Nebivolol is used with meals, and an acid -resistant between meals, both treatments can be prescribed at the same time.
Combining nebivolol and nicardipine increases the plasma concentrations of both drugs but does not change the clinical effect. Simultaneous use with alcohol, Furosemid or hydrochlorothiazid does not affect the pharmacokinetics of Nebivolol. Nebivolol does not affect Warfarin's pharmacokinetics and pharmacokinetics.
related to hydrochlorothiazid
When used with the following drugs, it may interact related to hydrochlorothiazid:
Alcohol, barbiturate or addictive sleeping pills: Increasing the potential of hypotension.
Anti -diabetic drugs (oral and insulin drugs): The dose adjustment is needed due to hyperlem of blood glucose.
corticosteroid, ACTH: increase power outages, especially hypokalemia.
Amines of hypertension (eg norepinephrin): may reduce response to hypertension, but not enough to prevent use.
muscle relaxants (eg tuboCurarin): may increase response to muscle relaxants.
Lithi: Do not use with diuretics, because of reducing lithium clearance and increased toxicity of this substance.
Non -steroid anti -inflammatory drugs: may reduce diuretic, sodium urinary effects and lower blood pressure effects in some patients. So if used with, must monitor to see if it is effective for diuretic.
quinidine: easily causing torsion, vibration causes death.
Thiazid reduces the effects of anticoagulants, gout medications.
Thiazid increases the effects of anesthesia, glycosid, vitamin D.
cholestyramin or colestipol: potential to attach thiazid diuretics, reducing the absorption of these drugs through the gastrointestinal tract.
thiazid increases the toxicity of digitalis.
Thiazid increases the risk of arrhythmia with drugs that extend QT about Astemizol, Terfenadin, Halofantrin, Pimozide and Sotalol.
To avoid interaction between drugs, notify the doctor or pharmacist the drugs being used.
Storage
Leave a cool place, avoid light, temperature below 30⁰C.
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