Lomiphene (Clomiphene Citrate) 50mg

Product Description
ClomiPHENE citrate is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl) phenoxy] triethylamine citrate (1:1).  It has a molecular formula of C26H28CINO ∙C6H8O7 and a molecular weight of 598.09.

ClomiPHENE citrate is a white to pale yellow, essentially odorless, crystalline powder.  It is freely soluble in methanol; soluble in ethanol; slightly soluble in acetone, water, and chloroform; and insoluble in ether.

ClomiPHENE citrate is a mixture of two geometric isomers [cis (zuclomiPHENE) and trans (enclomiPHENE)] containing between 30% and 50% of the cis-isomer.

Each white scored tablet contains 50 mg clomiPHENE citrate USP. The tablet also contains the following inactive ingredients:  lactose, microcrystalline cellulose, starch, colloidal silicon dioxide, magnesium stearate and sodium starch glycolate.

CLINICAL PHARMACOLOGY:
Action:

ClomiPHENE citrate is a drug of considerable pharmacologic potency.  With careful selection and proper management of the patient, clomiPHENE citrate has been demonstrated to be a useful therapy for the anovulatory patient desiring pregnancy.

ClomiPHENE citrate is capable of interacting with estrogen-receptor-containing tissues, including the hypothalamus, pituitary, ovary, endometrium, vagina, and cervix.  It may compete with estrogen for estrogen-receptor-binding sites and may delay replenishment of intracellular estrogen receptors.  ClomiPHENE citrate initiates a series of endocrine events culminating in a preovulatory gonadotropin surge and subsequent follicular rupture.  The first endocrine event in response to a course of clomiPHENE citrate therapy is an increase in the release of pituitary gonadotropins.  This initiates steroidogenesis and folliculogenesis, resulting in growth of the ovarian follicle and an increase in the circulating level of estradiol.  Following ovulation, plasma progesterone and estradiol rise and fall as they would in a normal ovulatory cycle.

Available data suggest that both the estrogenic and antiestrogenic properties of clomiPHENE may participate in the initiation of ovulation.  The two clomiPHENE isomers have been found to have mixed estrogenic and antiestrogenic effects, which may vary from one species to another.  Some data suggest that zuclomiPHENE has greater estrogenic activity than enclomiPHENE.

ClomiPHENE citrate has no apparent progestational, androgenic, or antiandrogenic effects and does not appear to interfere with pituitary-adrenal or pituitary-thyroid function.

Although there is no evidence of a “carryover effect” of clomiPHENE citrate, spontaneous ovulatory menses have been noted in some patients after clomiPHENE citrate therapy.


Pharmacokinetics:
Based on early studies with 14C-labeled clomiPHENE citrate, the drug was shown to be readily absorbed orally in humans and excreted principally in the feces.  Cumulative urinary and fecal excretion of the 14C averaged about 50% of the oral dose and 37% of an intravenous dose after 5 days.  Mean urinary excretion was approximately 8% with fecal excretion of about 42%.

Some 14C label was still present in the feces 6 weeks after administration.  Subsequent single-dose studies in normal volunteers showed that zuclomiPHENE (cis) has a longer half-life than enclomiPHENE (trans).  Detectable levels of zuclomiPHENE persisted for longer than a month in these subjects.  This may be suggestive of stereo-specific enterohepatic recycling or sequestering of the zuclomiPHENE.  Thus, it is possible that some active drug may remain in the body during early pregnancy in women who conceive in the menstrual cycle during clomiPHENE citrate therapy.

CLINICAL STUDIES:

During clinical investigations, 7578 patients received clomiPHENE citrate, some of whom had impediments to ovulation other than ovulatory dysfunction (see INDICATIONS AND USAGE).  In those clinical trials, successful therapy characterized by pregnancy occurred in approximately 30% of these patients.

There were a total of 2635 pregnancies reported during the clinical trial period.  Of those pregnancies, information on outcome was only available for 2369 of the cases.  Table 1 summarizes the outcome of these cases.

Of the reported pregnancies, the incidence of multiple pregnancies was 7.98%: 6.9% twin, 0.5% triplet, 0.3% quadruplet, and 0.1% quintuplet.  Of the 165 twin pregnancies for which sufficient information was available, the ratio of monozygotic to dizygotic twins was about 1:5.  Table 1 reports the survival rate of the live multiple births.

A sextuplet birth was reported after completion of original clinical studies; none of the sextuplets survived (each weighed less than 400 g), although each appeared grossly normal.


Table 1  Outcome of Reported Pregnancies in Clinical Trials (n=2369)
Outcome Total Number of Pregnancies Survival Rate
*  Includes 28 ectopic pregnancies, 4 hydatidiform moles, and 1 fetus papyraceous.
†  Indicates percentage of surviving infants from these pregnancies.
Pregnancy Wastage

      Spontaneous Abortions                    483*
      Stillbirths                      24
Live Births

   Single Births                  1697 98.16%†
   Multiple Births                    165 83.25%†
The overall survival of infants from multiple pregnancies including spontaneous abortions, stillbirths, and neonatal deaths is 73%.


INDICATIONS AND USAGE:
ClomiPHENE citrate tablets USP is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy.  Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiPHENE citrate therapy.  Those patients most likely to achieve success with clomiPHENE therapy include patients with polycystic ovary syndrome (see WARNINGS: Ovarian Hyperstimulation Syndrome), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology.

Properly timed coitus in relationship to ovulation is important.  A basal body temperature graph or other appropriate tests may help the patient and her physician determine if ovulation occurred.  Once ovulation has been established, each course of clomiPHENE citrate therapy should be started on or about the 5th day of the cycle.  Long-term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles).  (See DOSAGE AND ADMINISTRATION and PRECAUTIONS.)

ClomiPHENE citrate tablets USP is indicated only in patients with demonstrated ovulatory dysfunction who meet the conditions described below (see CONTRAINDICATIONS):

 1. Patients who are not pregnant.
 2. Patients without ovarian cysts.  ClomiPHENE citrate should not be used in patients with ovarian enlargement except in those with polycystic ovary syndrome.  Pelvic examination is necessary prior to the first and each subsequent course of clomiPHENE citrate treatment.
 3. Patients without abnormal vaginal bleeding.  If abnormal vaginal bleeding is present, the patient should be carefully evaluated to ensure that neoplastic lesions are not present.
 4. Patients with normal liver function.
In addition, patients selected for clomiPHENE citrate therapy should be evaluated in regard to the following:

 1. Estrogen Levels.  Patients should have adequate levels of endogenous estrogen (as estimated from vaginal smears, endometrial biopsy, assay of urinary estrogen, or from bleeding in response to progesterone).  Reduced estrogen levels, while less favorable, do not preclude successful therapy.
 2. Primary Pituitary or Ovarian Failure.  ClomiPHENE citrate therapy cannot be expected to substitute for specific treatment of other causes of ovulatory failure.
 3. Endometriosis and Endometrial Carcinoma.  The incidence of endometriosis and endometrial carcinoma increases with age as does the incidence of ovulatory disorders.  Endometrial biopsy should always be performed prior to clomiPHENE citrate therapy in this population.
 4. Other Impediments to Pregnancy.  Impediments to pregnancy can include thyroid disorders, adrenal disorders, hyperprolactinemia, and male factor infertility.
 5. Uterine Fibroids.  Caution should be exercised when using clomiPHENE citrate in patients with uterine fibroids due to the potential for further enlargement of the fibroids.
There are no adequate and well-controlled studies that demonstrate the effectiveness of clomiPHENE citrate in the treatment of male infertility.  In addition, testicular tumors and gynecomastia have been reported in males using clomiPHENE.  The cause and effect relationship between reports of testicular tumors and the administration of clomiPHENE citrate is not known.

Although the medical literature suggests various methods, there is no universally accepted standard regimen for combined therapy (i.e., clomiPHENE citrate in conjunction with other ovulation-inducing drugs).  Similarly, there is no standard clomiPHENE citrate regimen for ovulation induction in in vitro fertilization programs to produce ova for fertilization and reintroduction.  Therefore, clomiPHENE is not recommended for these uses.


CONTRAINDICATIONS:
Hypersensitivity:

ClomiPHENE is contraindicated in patients with a known hypersensitivity or allergy to clomiPHENE citrate or to any of its ingredients.

Pregnancy:

ClomiPHENE should not be administered during pregnancy.  ClomiPHENE citrate may cause fetal harm in animals (see Animal Fetotoxicity).  Although no causative evidence of a deleterious effect of clomiPHENE citrate therapy on the human fetus has been established, there have been reports of birth anomalies which, during clinical studies, occurred at an incidence within the range reported for the general population (see Fetal/Neonatal Anomalies and Mortality; ADVERSE REACTIONS).

To avoid inadvertent clomiPHENE citrate administration during early pregnancy, appropriate tests should be utilized during each treatment cycle to determine whether ovulation occurs.  The patient should be evaluated carefully to exclude pregnancy, ovarian enlargement, or ovarian cyst formation between each treatment cycle.  The next course of clomiPHENE citrate therapy should be delayed until these conditions have been excluded.

Fetal/Neonatal Anomalies and Mortality.  The following fetal abnormalities have been reported subsequent to pregnancies following ovulation induction therapy with clomiPHENE citrate during clinical trials.  Each of the following fetal abnormalities were reported at a rate of <1% (experiences are listed in order of decreasing frequency): Congenital heart lesions, Down syndrome, club foot, congenital gut lesions, hypospadias, microcephaly, harelip and cleft palate, congenital hip, hemangioma, undescended testicles, polydactyly, conjoined twins and teratomatous malformation, patent ductus arteriosus, amaurosis, arteriovenous fistula, inguinal hernia, umbilical hernia, syndactyly, pectus excavatum, myopathy, dermoid cyst of scalp, omphalocele, spina bifida occulta, ichthyosis, and persistent lingual frenulum.  Neonatal death and fetal death/stillbirth in infants with birth defects have also been reported at a rate of <1%.  The overall incidence of reported birth anomalies from pregnancies associated with maternal clomiPHENE citrate ingestion during clinical studies was within the range of that reported for the general population.

In addition, reports of birth anomalies have been received during postmarketing surveillance of clomiPHENE citrate. (see ADVERSE REACTIONS):

Animal Fetotoxicity:

 Oral administration of clomiPHENE citrate to pregnant rats during organogenesis at doses of 1 to 2 mg/kg/day resulted in hydramnion and weak, edematous fetuses with wavy ribs and other temporary bone changes.  Doses of 8 mg/kg/day or more also caused increased resorptions and dead fetuses, dystocia, and delayed parturition, and 40 mg/kg/day resulted in increased maternal mortality.  Single doses of 50 mg/kg caused fetal cataracts, while 200 mg/kg caused cleft palate.

Following injection of clomiPHENE citrate 2 mg/kg to mice and rats during pregnancy, the offspring exhibited metaplastic changes of the reproductive tract.  Newborn mice and rats injected during the first few days of life also developed metaplastic changes in uterine and vaginal mucosa, as well as premature vaginal opening and anovulatory ovaries.  These findings are similar to the abnormal reproductive behavior and sterility described with other estrogens and antiestrogens.

In rabbits, some temporary bone alterations were seen in fetuses from dams given oral doses of 20 or 40 mg/kg/day during pregnancy, but not following 8 mg/kg/day.  No permanent malformations were observed in those studies.  Also, rhesus monkeys given oral doses of 1.5 to 4.5 mg/kg/day for various periods during pregnancy did not have any abnormal offspring.

Liver Disease:

 ClomiPHENE citrate therapy is contraindicated in patients with liver disease or a history of liver dysfunction (see also INDICATIONS AND USAGE and ADVERSE REACTIONS).

Abnormal Uterine Bleeding:

 ClomiPHENE citrate is contraindicated in patients with abnormal uterine bleeding of undetermined origin (see INDICATIONS AND USAGE).

Ovarian Cysts:

 ClomiPHENE citrate is contraindicated in patients with ovarian cysts or enlargement not due to polycystic ovarian syndrome (see INDICATIONS AND USAGE and WARNINGS).

Other:

 ClomiPHENE citrate is contraindicated in patients with uncontrolled thyroid or adrenal dysfunction or in the presence of an organic intracranial lesion such as pituitary tumor (see INDICATIONS and USAGE).


WARNINGS:
Visual Symptoms:

Patients should be advised that blurring or other visual symptoms such as spots or flashes (scintillating scotomata) may occasionally occur during therapy with clomiPHENE citrate.  These visual symptoms increase in incidence with increasing total dose or therapy duration and generally disappear within a few days or weeks after clomiPHENE citrate therapy is discontinued. However, prolonged visual disturbances have been reported after clomiPHENE citrate therapy has been discontinued and these disturbances may be irreversible. Patients should be warned that these visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting.

These visual symptoms appear to be due to intensification and prolongation of afterimages. Symptoms often first appear or are accentuated with exposure to a brightly lit environment.  While measured visual acuity usually has not been affected, a study patient taking 200 mg clomiPHENE citrate daily developed visual blurring on the 7th day of treatment, which progressed to severe diminution of visual acuity by the 10th day.  No other abnormality was found, and the visual acuity returned to normal on the 3rd day after treatment was stopped.

Ophthalmologically definable scotomata and retinal cell function (electroretinographic) changes have also been reported.  A patient treated during clinical studies developed phosphenes and scotomata during prolonged clomiPHENE citrate administration, which disappeared by the 32nd day after stopping therapy.

Postmarketing surveillance of adverse events has also revealed other visual signs and symptoms during clomiPHENE citrate therapy (see ADVERSE REACTIONS).

While the etiology of these visual symptoms is not yet understood, patients with any visual symptoms should discontinue treatment and have a complete ophthalmological evaluation carried out promptly.

Ovarian Hyperstimulation Syndrome:

The ovarian hyperstimulation syndrome (OHSS) has been reported to occur in patients receiving clomiPHENE citrate therapy for ovulation induction.  In some cases, OHSS occurred following cyclic use of clomiPHENE citrate therapy or when clomiPHENE citrate was used in combination with gonadotropins.  Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with ovarian hyperstimulation syndrome (OHSS).

OHSS is a medical event distinct from uncomplicated ovarian enlargement. It may progress rapidly (within 24 hours to several days) to become a serious medical event. The clinical signs of this syndrome in severe cases can include gross ovarian enlargement, gastrointestinal symptoms, ascites, dyspnea, oliguria, and pleural effusion.  In addition, the following symptoms have been reported in association with this syndrome: pericardial effusion, anasarca, hydrothorax, acute abdomen, hypotension, renal failure, pulmonary edema, intraperitoneal and ovarian hemorrhage, deep venous thrombosis, torsion of the ovary, and acute respiratory distress.  The early warning signs of OHSS are abdominal pain and distention, nausea, vomiting, diarrhea, and weight gain.  Elevated urinary steroid levels, varying degrees of electrolyte imbalance, hypovolemia, hemoconcentration, and hypoproteinemia may occur.  Death due to hypovolemic shock, hemoconcentration, or thromboembolism has occurred.  Due to fragility of enlarged ovaries in severe cases, abdominal and pelvic examination should be performed very cautiously.  If conception results, rapid progression to the severe form of the syndrome may occur.

To minimize the hazard associated with occasional abnormal ovarian enlargement associated with clomiPHENE citrate therapy, the lowest dose consistent with expected clinical results should be used.  Maximal enlargement of the ovary, whether physiologic or abnormal, may not occur until several days after discontinuation of the recommended dose of clomiPHENE citrate.  Some patients with polycystic ovary syndrome who are unusually sensitive to gonadotropin may have an exaggerated response to usual doses of clomiPHENE citrate.  Therefore, patients with polycystic ovary syndrome should be started on the lowest recommended dose and shortest treatment duration for the first course of therapy (see DOSAGE AND ADMINISTRATION).

If enlargement of the ovary occurs, additional clomiPHENE citrate therapy should not be given until the ovaries have returned to pretreatment size, and the dosage or duration of the next course should be reduced.  Ovarian enlargement and cyst formation associated with clomiPHENE citrate therapy usually regress spontaneously within a few days or weeks after discontinuing treatment.  The potential benefit of subsequent clomiPHENE citrate therapy in these cases should exceed the risk.  Unless surgical indication for laparotomy exists, such cystic enlargement should always be managed conservatively.

A causal relationship between ovarian hyperstimulation and ovarian cancer has not been determined.  However, because a correlation between ovarian cancer and nulliparity, infertility, and age has been suggested, if ovarian cysts do not regress spontaneously, a thorough evaluation should be performed to rule out the presence of ovarian neoplasia.


PRECAUTIONS:
General:

Careful attention should be given to the selection of candidates for clomiPHENE citrate therapy.  Pelvic examination is necessary prior to clomiPHENE citrate treatment and before each subsequent course (see CONTRAINDICATIONS and WARNINGS).

Information for Patients:

Potential risks:

The purpose and risks of clomiPHENE citrate therapy should be presented to the patient before starting treatment.  It should be emphasized that the goal of clomiPHENE citrate therapy is ovulation for subsequent pregnancy.  The physician should counsel the patient with special regard to the following potential risks.

Visual Symptoms:

 Advise that blurring or other visual symptoms occasionally may occur during or shortly after clomiPHENE citrate therapy. It should be made clear that, in some instances, visual disturbances may be prolonged and, possibly, irreversible. Warn that visual symptoms may render such activities as driving a car or operating machinery more hazardous than usual, particularly under conditions of variable lighting (see WARNINGS).

The patient should be instructed to inform the physician whenever any unusual visual symptoms occur.  If the patient has any visual symptoms, treatment should be discontinued and complete ophthalmologic evaluation performed.

Abdominal/Pelvic Pain or Distention:

 Ovarian enlargement may occur during or shortly after therapy with clomiPHENE citrate.  To minimize the risks associated with ovarian enlargement, the patient should be instructed to inform the physician of any abdominal or pelvic pain, weight gain, discomfort, or distention after taking clomiPHENE citrate (see WARNINGS).

Multiple Pregnancy:

 Inform the patient that there is an increased chance of multiple pregnancy, including bilateral tubal pregnancy and coexisting tubal and intrauterine pregnancy, when conception occurs in relation to clomiPHENE citrate therapy.  The potential complications and hazards of multiple pregnancy should be explained.

Pregnancy Wastage and Birth Anomalies:

 The physician should explain the assumed risk of any pregnancy, whether ovulation is induced with the aid of clomiPHENE citrate or occurs naturally.  The patient should be informed of the greater risks associated with certain characteristics or conditions of any pregnant woman, eg, age of female and male partner, history of spontaneous abortions, Rh genotype, abnormal menstrual history, infertility history, organic heart disease, diabetes, exposure to infectious agents such as rubella, familial history of birth anomaly, that may be pertinent to the patient for whom clomiPHENE citrate is being considered.  Based upon the evaluation of the patient, genetic counseling may be indicated.

The overall incidence of reported birth anomalies from pregnancies associated with maternal clomiPHENE citrate ingestion during the investigational studies was within the range of that reported in published references for the general population.  (See CONTRAINDICATIONS: Pregnancy.)

During clinical investigation, the experience from patients with known pregnancy outcome (Table 1) show a spontaneous abortion rate of 20.4% and stillbirth rate of 1.0%.  (See CLINICAL PHARMACOLOGY)

Drug Interactions:

Drug interactions with clomiPHENE citrate have not been documented.


Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term toxicity studies in animals have not been performed to evaluate the carcinogenic or mutagenic potential of clomiPHENE citrate.

Oral administration of clomiPHENE citrate to male rats at doses of 0.3 or 1 mg/kg/day caused decreased fertility, while higher doses caused temporary infertility.  Oral doses of 0.1 mg/kg/day in female rats temporarily interrupted the normal cyclic vaginal smear pattern and prevented conception.  Doses of 0.3 mg/kg/day slightly reduced the number of ovulated ova and corpora lutea, while 3 mg/kg/day inhibited ovulation.

Pregnancy:

Pregnancy Category X. (See CONTRAINDICATIONS.)

Nursing Mothers:

It is not known whether clomiPHENE citrate is excreted in human milk.  Because many drugs are excreted in human milk, caution should be exercised if clomiPHENE citrate is administered to a nursing woman.  In some patients, clomiPHENE citrate may reduce lactation.

Ovarian Cancer:

Prolonged use of clomiPHENE citrate tablets USP may increase the risk of a borderline or invasive ovarian tumor (see ADVERSE REACTIONS).


ADVERSE REACTIONS:
Clinical Trial Adverse Events:

ClomiPHENE citrate, at recommended dosages, is generally well tolerated.  Adverse reactions usually have been mild and transient and most have disappeared promptly after treatment has been discontinued.  Adverse experiences reported in patients treated with clomiPHENE citrate during clinical studies are shown in Table 2.


Table 2.  Incidence of Adverse Events in Clinical Studies (Events Greater than 1%)(n = 8029*)
Adverse Event %
*Includes 498 patients whose reports may have been duplicated in the event totals and could not be distinguished as such.  Also, excludes 47 patients who did not report symptom data.
Ovarian Enlargement 13.6
Vasomotor Flushes 10.4
Abdominal-Pelvic Discomfort/Distention/Bloating 5.5
Nausea and Vomiting 2.2
Breast Discomfort 2.1
Visual Symptoms 1.5
    Blurred vision, lights, floaters, waves, unspecified visual complaints, photophobia, diplopia, scotomata, phosphenes
Headache 1.3
Abnormal Uterine Bleeding 1.3
    Intermenstrual spotting, menorrhagia
The following adverse events have been reported in fewer than 1% of patients in clinical trials: Acute abdomen, appetite increase, constipation, dermatitis or rash, depression, diarrhea, dizziness, fatigue, hair loss/dry hair, increased urinary frequency/volume, insomnia, light-headedness, nervous tension, vaginal dryness, vertigo, weight gain/loss.

Patients on prolonged clomiPHENE citrate therapy may show elevated serum levels of desmosterol.  This is most likely due to a direct interference with cholesterol synthesis.  However, the serum sterols in patients receiving the recommended dose of clomiPHENE citrate are not significantly altered. Ovarian cancer has been infrequently reported in patients who have received fertility drugs.  Infertility is a primary risk factor for ovarian cancer; however, epidemiology data suggest that prolonged use of clomiPHENE may increase the risk of a borderline or invasive ovarian tumor.

Postmarketing Adverse Events:

The following adverse experiences were reported spontaneously with clomiPHENE citrate.  The cause and effect relationship of the listed events to the administration of clomiPHENE citrate is not known.

Dermatologic:

 Acne, allergic reaction, erythema, erythema multiforme, erythema nodosum, hypertrichosis, pruritus, urticaria.

Central Nervous System:

 Migraine headache, paresthesia, seizure, stroke, syncope

Psychiatric:

 Anxiety, irritability, mood changes, psychosis

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Lioresal (Baclofen) 10mg

Description:

Baclofen is a muscle relaxer and an antispastic agent.
Baclofen is used to treat muscle symptoms caused by multiple sclerosis, including spasm, pain, and stiffness.
Baclofen may also be used for purposes not listed in this medication guide.

Baclofen may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of baclofen. Do not use baclofen at a time when muscle tone is needed to assure safe balance and movement for certain activities. In some situations, it may endanger your physical safety to be in a state of reduced muscle tone.

You may have withdrawal symptoms such as seizures or hallucinations, when you stop using baclofen after using it over a long period of time.

Do not stop using baclofen without first talking to your doctor. You may need to use less and less before you stop the medication completely. Using baclofen may increase your risk of developing an ovarian cyst. Talk with your doctor about your specific risk.

BEFORE TAKING BACLOFEN:
You should not use baclofen if you are allergic to it.

To make sure you can safely take baclofen, tell your doctor if you have any of these other conditions:

kidney disease;
epilepsy or other seizure disorder; or
a history of stroke or blood clots.
Oral: Initial dose: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day.
Maintenance dose: 40-80 mg/day.
80 mg/day doses should be administered in 4 divided doses.

Intrathecal: Test dose: 50 mcg (in a volume of 1 mL) injected into the intrathecal space by barbotage over at least 1 minute. Observe patient for 4-8 hours for a positive response.
Second test dose: If no positive response to first test dose, 75 mcg (in a volume of 1.5 mL) may be administered 24 hours later.
Third test dose: If no positive response to second test dose, 100 mcg (in a volume of 2 mL) may be administered 24 hours later. If no positive response to third test dose, the patient should not be considered for chronic intrathecal therapy.
The test dose that received a positive response should be doubled and given over 24 hours. If the test dose maintained a positive response for > 12 hours, the starting daily dose should be the same as the effective test dose. After 24 hours, the dose may be titrated by 10%-20% increments every day until the desired clinical effect is achieved. Over time, many patients will require gradual dose increases to maintain the desired clinical effect. Patients have been maintained on daily doses of 12-1500 mcg. Most patients require 300-800 mcg/day.

Usual Adult Dose of Baclofen for Trigeminal Neuralgia:

Oral: Initial dose: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day.
Maintenance dose: 40-80 mg/day.
80 mg/day doses should be administered in 4 divided doses.

Intrathecal: Test dose: 50 mcg (in a volume of 1 mL) injected into the intrathecal space by barbotage over at least 1 minute. Observe patient for 4-8 hours for a positive response.
Second test dose: If no positive response to first test dose, 75 mcg (in a volume of 1.5 mL) may be administered 24 hours later.
Third test dose: If no positive response to second test dose, 100 mcg (in a volume of 2 mL) may be administered 24 hours later. If no positive response to third test dose, the patient should not be considered for chronic intrathecal therapy.
The test dose that received a positive response should be doubled and given over 24 hours. If the test dose maintained a positive response for > 12 hours, the starting daily dose should be the same as the effective test dose. After 24 hours, the dose may be titrated by 10%-20% increments every day until the desired clinical effect is achieved. Over time, many patients will require gradual dose increases to maintain the desired clinical effect. Patients have been maintained on daily doses of 12-1500 mcg. Most patients require 300-800 mcg/day.

Usual Adult Dose of Baclofen for Hiccups:

Initial dose: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day.
Maintenance dose: 40-80 mg/day.
80 mg/day doses should be administered in 4 divided doses.

Usual Adult Dose of Baclofen for Cerebral Spasticity:

Intrathecal: Test dose: 50 mcg (in a volume of 1 mL) injected into the intrathecal space by barbotage over at least 1 minute. Observe patient for 4-8 hours for a positive response.
Second test dose: If no positive response to first test dose, 75 mcg (in a volume of 1.5 mL) may be administered 24 hours later.
Third test dose: If no positive response to second test dose, 100 mcg (in a volume of 2 mL) may be administered 24 hours later. If no positive response to third test dose, the patient should not be considered for chronic intrathecal therapy.
If a positive response has occurred following a test dose, an intrathecal infusion device may be surgically implanted.
The test dose that received a positive response should be doubled and given over 24 hours. If the test dose maintained a positive response for > 12 hours, the starting daily dose should be the same as the effective test dose. After 24 hours, the dose may be titrated by 10%-20% increments every day until the desired clinical effect is achieved. Over time, many patients will require gradual dose increases to maintain the desired clinical effect. Patients have been maintained on daily doses of 12-1500 mcg. Most patients require 300-800 mcg/day.

WHAT OTHER DRUGS WILL AFFECT BACLOFEN?
Before using baclofen, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, other muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by baclofen.

This list is not complete and other drugs may interact with baclofen. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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Finexal Trenbolone Acetate 250mg

Product Description
Brand Name: Finexal 100
Active compound: Trenbolone Acetate

Finexal (Trenbolone Acetate) is a very potent androgen with strong anabolic activity. It is well suited for the rapid buildup of strength and muscle mass, usually providing the user exceptional results in a relatively short time period. The anabolic effect of this drug is often compared to popular bulking agents such as testosterone or Danabol DS, with one very important difference. Finexal (Trenbolone Acetate) does not convert to estrogen. This is indeed a very unique compound since mass drugs, almost as a rule, will aromatize (or cause other estrogen related troubles) heavily. When we think of taking milder (regarding estrogen) steroids we usually expect much weaker muscle growth, but not so with Finexal (Trenbolone Acetate). Here we do not have to worry about estrogen related side effects, yet still have an extremely potent mass/strength drug. There is no noticeable water retention, so the mass gained during a cycle of Finexal (Trenbolone Acetate) will be very hard and defined (providing fat levels are low enough). Gynecomastia is also not much of a concern, so there shouldn't be any need to addition an anti-estrogen if Finexal (Trenbolone Acetate) is the only steroid administered.

The high androgen level resulting from this steroid, in the absence is excess estrogen, can also accelerate the burning of body fat. The result should be a much tighter physique, hopefully without the need for extreme dieting. Finexal (Trenbolone Acetate) can therefore help bring about an incredibly hard, ripped physique and is an ideal product for competitive bodybuilders.

Finexal (Trenbolone Acetate) is notably more potent than testosterone, and has an effect that is as much as three times as strong on a milligram for milligram basis. Likewise we can expect to see some level of androgenic side effects with use of this compound. Oily skin, aggressive behavior, acne and hair loss are therefore not uncommon during a cycle with this steroid. The androgenic nature of this drug of course makes it a very risky item for women to use, the chance for virilization symptoms extremely high with such a potent androgen.

Finexal (Trenbolone Acetate) is also much more potent than testosterone at suppressing endogenous androgen production. This makes clear the fact that estrogen is not the only culprit with negative feedback inhibition, as here there is no buildup of this hormone to report here. There is however some activity as a progestin inherent in this compound, as Finexal (Trenbolone Acetate) is a 19-nortestosterone (nandrolone) derivative (a trait characteristic of these compounds). However it seems likely that much of its suppressive nature still stems from its powerful androgen action. With the strong impact Finexal (Trenbolone Acetate) has on endogenous testosterone, of course the use of a stimulating drug such as HCG and/or Clomid/Nolvadex is recommended when concluding steroid therapy (a combination is preferred). Without their use it may take a prolonged period of time for the hormonal balance to resume, as the testes may at first not be able to normally respond to the resumed output of endogenous gonadotropins due to an atrophied state. Those who have used Finexal (Trenbolone Acetate) regularly would often claim it to be indispensable. A daily dosage of 37.5-75 mg is the most popular range when running a cycle. While Finexal (Trenbolone Acetate) is quite potent when used alone, it was generally combined with other steroids for an even greater effect. During a cutting phase one could add a non-aromatizing anabolic such as Winstrol or Primobolan. Such combinations will elicit a greater level density and hardness to the muscle. One could also bulk with this drug, with the addition of stronger compounds like Danabol DS or Testosterone. While the mass gain would be quite formidable with such a stack, some level of water retention would probably also accompany it. Moderately effective anabolics such Deca-Durabolin or Equipoise would be somewhat of a halfway point, providing extra strength and mass but without the same level of water bloat we see with more readily aromatized steroids.

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Lasix 40mg by Aventis

Lasix 40mg by Aventis Generic Name: furosemide Brand names: Lasix, Diaqua-2, Lo-Aqua Lasix treats fluid retention (edema) in people with congestive heart failure, liver disease, or a kidney disorder such as nephrotic syndrome

Product Description
PHARMACOLOGICAL CLASSIFICATION:

A 18.1: Diuretics

PHARMACOLOGICAL ACTION:
LASIX® inhibits the reabsorption of sodium and water predominantly in the ascending loop of Henle but also in the proximal tubule. It is often possible, in situations where other methods of treatment fail to induce diuresis, to increase the excretion of sodium and water with LASIX®, even when glomerular filtration rate is markedly impaired.
LASIX® lowers pathologically raised blood pressure, but does not affect normal levels.
With oral administration of LASIX®, the onset of action is rapid, usually within half an hour. Peak action is usually achieved after two hours, and the duration of action is 4 to 5 hours. With parenteral administration, the onset of action is even more rapid.

INDICATIONS:
Cardiac oedema: All forms of cardiac oedema in conjunction with adequate glycoside therapy.
Ascites due to cirrhosis of the liver, mechanical obstruction or cardiac failure.
Renal oedema in nephrotic syndrome.
Oedema occurring during the last three months of pregnancy-pre-eclamptic toxaemia and eclampsia.
As an adjunct in acute pulmonary oedema.
Cerebral oedema.
Hypertension of mild to moderate degree.
Barbiturate poisoning (using the principle of "forced diuresis").
Burns: to reduce local oedema and to prevent oliguria from progressing to complete anuria.

CONTRA-INDICATIONS:

Patients who are hypersensitive to furosemide or sulphonamides.
LASIX® is contra-indicated if increasing azotaemia and oliguria occur during treatment of severe progressive renal disease, anuria, hypokalaemia, hyponatraemia, hypovolaemia with or without hypotension. In hepatic coma and in states of electrolyte depletion, therapy with LASIX® should not be instituted until the basic condition is corrected or improved.
Furosemide should not be given to lactating women.
Furosemide should be administered during pregnancy only if strictly indicated, and then only for short periods of time.

DOSAGE AND DIRECTIONS FOR USE:

The usual dose of LASIX® is 20 mg to 80 mg per day given as a single dose preferably in the morning.
This dose may, however, be increased depending on the response of the patient. Six hours after a 40 mg dose, 80 mg may be administered and, if necessary, after another six hours, 120 mg. After the oedema is controlled, maintenance therapy is continued at 20 mg to 40 mg daily. Daily doses exceeding 120 mg should preferably be distributed over two to three individual doses.
For the treatment of hypertension of mild or moderate degree, a daily dosage of 40 to 80 mg is taken orally. In combination with other hypotensive drugs, lower doses will often suffice.
Intravenous or intramuscular administration of LASIX® is indicated in all cases where intestinal absorption is impaired or prompt diuresis required. The rapid and powerful effect produced by intravenous injection may result in a transitory fall in plasma volume.
Pulmonary oedema: Initial dose 40 mg intravenously. If necessary, the injection may be repeated after approximately 20 minutes.
Forceddiuresis (eg. management of barbiturate poisoning):
20 mg to 40 mg LASIX® is given in addition to infusion of electrolyte solution. Further treatment depends on the elimination of urine and must include substitution of the fluid and electrolyte losses. In poisoning with acid or basic substances the elimination rate can be further increased by alkalisation or acidification of the urine, respectively.

Infants and Children under 15 years:

Children generally receive an oral dose of 2 mg/kg body mass per day in divided doses. This may be titrated to a maximum of 6 mg/kg.
Parenteral administration (if necessary, continuous drip infusion) is indicated only in life-threatening conditions.
In this case, infants/children receive parenteral doses of 1 mg/kg body mass per day up to a maximum of 20 mg per day.


Administration:

Intravenous or intramuscular administration of LASIX® is indicated in all cases where intestinal absorption is impaired or rapid fluid elimination is necessary. Intravenously, LASIX®should be injected slowly. The rate of injection of 4 mg per minute should not be exceeded. During long-term treatment, serum creatinine and urea and also electrolytes, in particular potassium, calcium, chloride and bicarbonate, should be regularly checked.

Furosemide, being an anthranilic acid derivative, dissolves in alkaline media with salt formation. The solution for parenteral application contains the sodium salt of the carboxylic acid without a solubilizer. The solution has a pH of about 9 but no buffer capacity, which means that the drug may precipitate at pH values below 7. If the ready-to-use solution has a pH ranging from weakly alkaline to neutral, the mixture may be used for up to 24 hours.

LASIX® must not be mixed with other drugs in the same injection syringe.
The duration of treatment is at the physician's discretion.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:

Although administration of LASIX® only rarely leads to hypokalaemia, a potassium rich diet (lean meat, potatoes, bananas, tomatoes, cauliflower, spinach, dried fruit, etc.) is always advisable. Treatment with potassium-containing or potassium sparing preparations may be indicated.
As with other diuretics, electrolyte and water balance may be disturbed as a result of diuresis after prolonged therapy.
Mainly at the start of the treatment, excessive diuresis, particularly in elderly patients, may give rise to circulatory disturbances, such as a feeling of pressure in the head, vertigo or visual impairment: in extreme cases hypovolaemia, dehydration, dryness of mouth, circulatory collapse and blood coagulation disorders may also occur. However, with individualized dosage, acute haemodynamic reactions are generally not to be expected, although diuresis sets in rapidly.
LASIX® may cause potassium depletion, especially in cases of low potassium diet, vomiting or chronic diarrhoea. In addition, diseases such as cirrhosis of the liver may cause a predisposition to potassium deficiency states. Appropriate surveillance and replacement therapy are necessary in such cases.
If salt intake is restricted too much, sodium deficiency may produce a fall in blood pressure, calf muscle cramps, anorexia, weakness, dizziness, drowsiness, vomiting and confusional states.
The serum calcium level may be reduced under LASIX® therapy: in very rare cases tetany has been observed. In premature infants calcium salts may be deposited in the renal tissue (nephrocalcinosis). When administered to premature infants with respiratory distress syndrome in the first few weeks after birth, diuretic treatment with furosemide may accentuate the risk of a patent ductus arteriosus.
Gastro-intestinal disorders (e.g. nausea, vomiting, diarrhoea) or allergic reactions (e.g. rashes, vasculitis, interstitial nephritis, photosensitivity, vesicular cutaneous eruptions, fever and shock) and changes of the blood picture (leukopenia, agranulocytosis, haemolytic anaemia, thrombocytopenia) may occasionally be observed.
Anaphylactic shock, though rare, is an acute life-threatening reaction, and may occur only during parenteral administration.
Anaphylactic shock must be treated with the usual agents i.e. adrenaline, corticosteroids and antihistamines.
Symptoms of obstructed micturition (e.g. in hydronephrosis, prostatic hypertrophy, uretherostenosis) may become manifest or aggravated under the action of diuretics.
In common with other diuretics, treatment with LASIX® may induce a transient rise in serum creatinine and urea levels.
It should be remembered that an increase in uric acid concentration in the blood may precipitate attacks of gout in predisposed patients.
Serum cholesterol and triglyceride levels may increase under LASIX® treatment but will usually return to normal under long-term treatment, within six months.
In rare cases manifest diabetes mellitus may be aggravated by furosemide treatment and latent diabetes may become manifest. Isolated cases of acute pancreatitis have been reported in which the treatment with saluretics over several weeks was considered a causal factor, including also a few cases following therapy with furosemide.
Disorders of hearing after furosemide are rare and in most cases reversible. This possibility should be borne in mind, especially if furosemide is injected too rapidly and in particular in patients with renal insufficiency (see Administration).
Pre-existing metabolic alkalosis may be aggravated by furosemide treatment (e.g. in decompensated cirrhosis of the liver).
In individual cases the ability to drive or to operate machinery may be impaired, especially at the commencement of treatment or when changing over from other medicines or when alcohol is consumed during LASIX® therapy.

Interactions:

When a cardiac glycoside is administered concurrently it should be remembered that potassium deficiency increases the sensitivity of the myocardium to digitalis. In case of glucocorticoid medication or abuse of laxatives the risk of increased potassium loss should be borne in mind.
LASIX® may potentiate the nephrotoxic effects of certain antibiotics (e.g. aminoglycosides). Therefore, LASIX® should be used with caution in patients with antibiotic-induced renal impairment.
It should be borne in mind that the ototoxicity of aminoglycoside antibiotics (e.g. kanamycin, gentamicin, tobramycin) may be potentiated when LASIX® is used concurrently. The hearing defects that result may be irreversible. Therefore this drug combination should be restricted to vital indications. As the concomitant administration of cisplatin and parenteral LASIX® carries the risk of inducing hearing defects, the two medicines should not be used simultaneously.
Sometimes LASIX® may diminish the potency of other medicines (e.g. the effect of anti-diabetics and pressor amines) or potentiates their effect (e.g. in the case of salicylates, theophylline, lithium and curaremimetic muscle relaxants).
The action of other hypotensive medicines may be potentiated by LASIX®. Especially in combination with ACE-inhibitors a marked fall in blood pressure may be seen. Non-steroidal anti-inflammatory agents (e.g. indomethacin, acetylsalicylic acid) may antagonise the action of LASIX® and may cause renal failure in case of pre-existing hypovolaemia.
Concurrent administration of furosemide and sucralfate should be avoided as sucralfate reduces the absorption of furosemide and hence weakens its effect.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

After the ingestion of an overdose there is some danger of dehydration and electrolyte depletion due to excessive diuresis.
The guiding principle of treatment is water and electrolyte replacement in accordance with urine output (with monitoring of carbohydrate metabolism if necessary). If difficulty in micturition is proved or suspected, as in cases of prostatic hypertrophy or impairment of consciousness, care must be taken to ensure a free outflow of urine from the bladder.

IDENTIFICATION:

Tablet 20 mg: A white scored tablet with the company logo on the one side, and coded DLF on the other side. Diameter: 6 mm.
Tablet 40 mg: A white, scored tablet with the company logo on the one side, and coded DLI on the other side. Diameter: 8 mm.
Tablet 80 mg: A white, flat tablet, 8-faceted, with a score line and "Lasix 80" imprinted on one side and the company logo on the other side.
Injection 2 mL: A clear, colourless solution in an amber glass ampoule.
Oral Solution: A clear orange-yellow solution with an odour of orange in a 100 mL amber glass bottle with a screw cap.

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Fulagra (Generic Sildenafil Citrate) 100mg

Fulagra (Generic Sildenafil Citrate) 100mg by C G is used to treat erection difficulties, such as erectile dysfunction (ED).

Product Description
Generic Name:
Sildenafil Citrate
It works by increasing the effects of nitric oxide (NO), a substance that serves many key functions in biological processes throughout the body. One of the most well known and important functions of NO is the dilation of blood vessels. This allows greater blood flow to the muscles, which of course can be valuable to an athlete during competition.
What is more interesting to me is the role of NO on muscles during resistance training. JE Anderson found that NO appears to be a vital signal in the activation of muscle satellite cells in response to damage. Satellite cell activation is the key first step in the repair and hypertrophy of muscle cells after heavy training. It may therefore enhance the hypertrophy response to exercise, working at the most basic and primary level of the process.

In addition to this, there is evidence that suggests that Viagra may work to amplify the "pump" response during training. The pump is thought to happen when contracting muscle fibers signal local vascular relaxation (increasing the blood flow to the working muscles). According to KS Lau and coworkers, NO generated by neuronal NO synthase in contracting skeletal muscle fibers may regulate vascular relaxation via a cGMP-mediated pathway. Since the mechanism of action for Viagra is amplification of the cGMP pathway, there is ample reason to believe that the drug may indeed affect the blood flow and pump to the muscle, and therefore indirectly aid in the hypertrophy response.

Common uses and directions for Sildenafil Citrate:
Normally nerves or blood vessels in men with male erectile dysfunction do not work properly, which prevents them from achieving an erection. It works to restore the blood flow to the penis making it easier to achieve and sustain longer erections.
  It increases the blood flow to the penis by helping the arteries in the penis relax and expand. As the arteries in the penis expand and harden, veins that normally carry away blood flow to the penis are compressed resulting in an erection.
  It takes at least 30 minutes before it starts to work, and remains active for up to 4 hours. The erection goes away after intercourse.
Men who are currently using medicines that contain nitrates, such as nitroglycerin should not use it because taken together they can lower the blood pressure too much. Kobra should not be used by women or children.

Sildenafil Citrate additional information:
Common uses
  is used to treat erection difficulties, such as erectile dysfunction (ED).

Directions:

  comes as a tablet containing 150 mg. sildenafil citrate, to take by mouth.
For most men, the recommended dose is 50 mg. taken, as needed, approximately 1 hour before sexual activity. However, sildenafil citrate may be taken anywhere from 4 hours to 0.5 hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day.

Precautions:

A starting dose of 25 mg. should be considered individuals of the age 65+ and in individuals with hepatic impairment or severe renal impairment.
Given the extent of the interaction with patients receiving concomitant therapy with ritonavir, it is recommended not to exceed a maximum single dose of 25 mg. of Viagra in any 48 hour period.
Sildenafil citrate potentiates the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors or nitrates in any form is therefore contraindicated.
Treatments for erectile dysfunction, including Kobra/Viagra, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.
Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months, patients with resting hypotension or hypertension, patients with cardiac failure or coronary artery disease and patients with retinitis pigmentosa should use Kobra/Viagra with great caution.
The safety of Viagra is unknown in patients with bleeding disorders and patients with active peptic ulceration.
Kobra/Viagra should be used with caution by individuals with anatomical deformation of the penis and by individuals who have conditions which may predispose them to priapism.
The safety and efficacy of combinations of Viagra with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

Possible side effects:

The most frequently observed side effects of Kobra/Viagra includes headache, flushing, dyspepsia and nasal congestion.
Less frequent side effects include erections that will not go away and vision changes. In the event that an erection persists longer than 4 hours, seek immediate medical assistance. Other less frequent side effects include urinary tract infection, abnormal vision, diarrhea, dizziness and rash.
If you notice other effects not listed above, contact your doctor.

Overdose:

If overdose of Kobra/Viagra/Fulagra is suspected, contact your local poison control center or emergency room immediately.

Additional information:

Keep Viagra/Kobra/Fulagra in a tightly closed container and out of reach of children. Store  at room temperature and away from excess heat and moisture (not in the bathroom).

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Glucophage 250mg by Merck

GLUCOPHAGE 250mg

Description
GLUCOPHAGE (metformin hydrochloride tablets) and GLUCOPHAGE XR (metformin hydrochlo-ride extended-release tablets) are oral antihyperglycemic drugs used in the management of type 2 diabetes. Metformin hydrochloride (N, N-dimethylimidodicarbonimidic diamide hydrochloride) is not chemically or pharmacologically related to any other classes of oral antihyperglycemic agents.

Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C 4 H 11 N 5 HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. 

GLUCOPHAGE tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Each tablet contains the inactive ingredients povidone and magnesium stearate. In addition, the coating for the 500-mg and 850-mg tablets contains hydroxypropyl methylcellulose (hypromellose) and the coating for the 1000-mg contains hydroxypropyl methylcellulose and polyethylene glycol. 

GLUCOPHAGE XR contains 500 mg of metformin hydrochloride as the active ingredient. Each tablet contains the inactive ingredients sodium carboxymethyl cellulose, hydroxypropyl methylcel-lulose, microcrystalline cellulose, and magnesium stearate. 

System Components and Performance GLUCOPHAGE XR tablets comprise a dual hydrophilic polymer matrix system. Metformin hydrochloride is combined with a drug release controlling polymer to form an "inner" phase, which is then incorporated as discrete particles into an "external" phase of a second polymer. After administration, fluid from the gastrointestinal (GI) tract enters the tablet, causing the polymers to hydrate and swell. Drug is released slowly from the dosage form by a process of diffusion through the gel matrix that is essen-tially independent of pH. The hydrated polymer system is not rigid and is expected to be broken up by normal peristalsis in the GI tract. The biologically inert components of the tablet may occasionally remain intact during GI transit and will be eliminated in the feces as a soft, hydrated mass

INDICATIONS:

Non-insulin dependent diabetes when diet has failed and especially if the patient is overweight. Glucophage can be given alone as initial therapy, or can be administered in combination with a sulphonylurea. In insulin-dependent diabetes, Glucophage may be given as an adjuvant to patients whose symptoms are poorly controlled.

CONTRA-INDICATIONS:

Sensitivity to metformin hydrochloride. Diabetic coma and ketoacidosis, impairment of renal function, chronic liver disease, cardiac failure and recent myocardial infarction. History of, or states associated with, lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), and conditions associated with hypoxemia. Pancreatitis. The use of Glucophage during pregnancy is not advised. There is no information available concerning the safety of Glucophage during lactation.

WARNINGS:

Sensitivity to metformin hydrochloride. Diabetic coma and ketoacidosis, impairment of renal function, chronic liver disease, cardiac failure and recent myocardial infarction. History of, or states associated with, lactic acidosis such as shock or pulmonary insufficiency, alcoholism (acute or chronic), and conditions associated with hypoxemia. Pancreatitis. The use of Glucophage during pregnancy is not advised. There is no information available concerning the safety of Glucophage during lactation.

DOSAGE AND DIRECTIONS FOR USE:

It is important that Glucophage tablets be taken in divided doses with meals.

Adults:

Initially, one 850 mg tablet twice a day or one 500 mg tablet three times a day, with or after food. Good diabetic control may be achieved within a few days, but it is not usual for the full effect to be delayed for up to two weeks. If control is incomplete a cautious increase in dosage to a maximum of 3 g daily is justified. Once control has been obtained it may be possible to reduce the dosage of Glucophage.

Children:

Glucophage is not recommended for use.

Elderly:

Glucophage is indicated in the elderly, but not when renal function is impaired.
Combination therapy - see "Special Precautions"

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:

Gastro-intestinal adverse effects with anorexia, nausea and vomiting. Metallic taste. Lactic acidosis has been associated with Glucophage but, has occurred to a greater extent in patients with contra-indications to therapy. In patients with a metabolic acidosis lacking evidence of ketoacidosis (ketonuria and ketonaemia) lactic acidosis should be suspected and Glucophage therapy stopped. Lactic acidosis is a medical emergency which must be treated in hospital.
Glucophage is excreted by the kidney and regular monitoring of renal function is advised in all diabetics. Glucophage therapy should be stopped 2-3 days before surgery and clinical investigations such as intravenous urography and intravenous angiography and reinstated only after control of renal function has been regained. The use of Glucophage is not advised in conditions which may cause dehydration or in patients suffering from serious infections, trauma or on low calorie intake.
Patients receiving continuous Glucophage therapy should have an annual estimation of Vitamin B12 levels because of reports of decreased Vitamin B12 absorption.
During concomitant therapy with a sulphonylurea, blood glucose should be monitored because combined therapy may cause hypoglycaemia. Stabilisation of diabetic patients with Glucophage and insulin should be carried out in hospital because of the possibility of hypoglycaemia until the correct ratio of the two drugs has been obtained.
Reduced renal clearance of Glucophage has been reported during cimetidine therapy, so a dose reduction should be considered. An interaction between Glucophage and anticoagulants is a possibility and dosage of the latter may need adjustment.
Contra-indications should be carefully observed.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:

Hypoglycaemia can occur when Glucophage is given concomitantly with a sulphonylurea, insulin or alcohol. In excessive dosage, and particularly if there is a possibility of accumulation, lactic acidosis may develop. Intense symptomatic and supportive therapy is recommended which should be particularly directed at correcting fluid loss and metabolic disturbance.

IDENTIFICATION:

Glucophage 500 mg Tablets - White, round, biconvex, film-coated tablets.
Glucophage 850 mg Tablets - White, round shallow, biconvex film-coated tablets.

PRESENTATION:

Glucophage 500 mg Tablets 500 mg - 100's and 500's
Glucophage 850 mg Tablets 850 mg - 60's and 300's

STORAGE INSTRUCTIONS:

Store below 25°C. Protect from light and moisture.
Keep out of reach of children.

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Levitra 10mg by Bayer

Generic Levitra is used to treat sexual function problems such as Impotence or Erectile Dysfunction. levitra 10 mg,

Product Description
Indication:

LEVITRA is a prescription medicine used for the treatment of erectile dysfunction (ED) in men.

Important Safety Information:

LEVITRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. With a sudden drop in blood pressure, you could get dizzy, faint, or have a heart attack or stroke.

Do not take LEVITRA if you:

Take any medications called “nitrates” (often used to control chest pain, also known as angina), or if you use recreational drugs called “poppers” like amyl nitrate and butyl nitrate. Nitrates may cause abnormally low blood pressure and LEVITRA may increase that risk.
Have been told by your healthcare provider not to have sexual activity because of health problems. Sexual activity can put an extra strain on your heart, especially if your heart is already weak from a heart attack or heart disease.
Tell all your healthcare providers that you take LEVITRA. If you need emergency medical care for a heart problem, it will be important for your healthcare provider to know when you last took LEVITRA.
LEVITRA does not protect a man or his partner from sexually transmitted diseases, including HIV.

Before taking LEVITRA:

tell your doctor about all your medical problems, including if you:

have heart problems such as angina, heart failure, irregular heartbeats, or have had a heart attack—ask your doctor if it is safe for you to have sexual activity
have low blood pressure or have high blood pressure that is not controlled
have had a stroke
have had a seizure
or any family members have a rare heart condition known as prolongation of the QT interval (long QT syndrome)
have liver problems
have kidney problems and require dialysis
have retinitis pigmentosa, a rare genetic (runs in families) eye disease
have ever had severe vision loss, or if you have an eye condition called non-arteritic anterior ischemic optic neuropathy (NAION)
have stomach ulcers
have a bleeding problem
have a deformed penis shape or Peyronie’s disease
have had an erection that lasted more than 4 hours
have blood cell problems such as sickle cell anemia, multiple myeloma, or leukemia
have hearing problems

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. LEVITRA and other medicines may affect each other. Especially tell your doctor if you take any of the following:
Medicines called alpha-blockers. These include Hytrin® (terazosin HCl), Flomax® (tamsulosin HCl), Cardura® (doxazosin mesylate), Minipress® (prazosin HCl), Uroxatral® (alfuzosin HCl), or Rapaflo® (silodosin). Alpha-blockers are sometimes prescribed for prostate problems or high blood pressure. In some patients the use of PDE5 inhibitor drugs, including LEVITRA, with alpha-blockers can lower blood pressure significantly, leading to fainting. You should contact the prescribing physician if alpha-blockers or other drugs that lower blood pressure are prescribed by another healthcare provider
Ritonavir (Norvir®) or indinavir sulfate (Crixivan®), saquinavir (Fortavase® or Invirase®) or atazanavir (Reyataz®)
Ketoconazole or itraconazole (such as Nizoral® or Sporanox®)
Erythromycin or clarithromycin

Do not use LEVITRA with other medicines or treatments for ED.
Tell your doctor if you take medicines that treat abnormal heartbeat. These include quinidine, procainamide, amiodarone, and sotalol. Patients taking these drugs should not use LEVITRA.
Take LEVITRA exactly as your doctor prescribes. LEVITRA comes in different doses (2.5 mg, 5 mg, 10 mg, and 20 mg). For most men, the recommended starting dose is 10 mg. Take LEVITRA no more than once a day. Doses should be taken at least 24 hours apart. Some men can take only a low dose of LEVITRA because of medical conditions or medicines they take. Your doctor will prescribe the dose that is right for you
If you are older than 65 or have liver problems, your doctor may start you on a lower dose of LEVITRA
If you have prostate problems or high blood pressure for which you take medicines called alpha-blockers, your doctor may start you on a lower dose of LEVITRA
If you are taking certain other medicines your doctor may prescribe a lower starting dose and limit you to one dose of LEVITRA in a 72-hour (3 days) period.
The most common side effects with LEVITRA are headache, flushing, stuffy or runny nose, indigestion, upset stomach, or dizziness.

LEVITRA may uncommonly cause:

An erection that lasts more than 4 hours. Get medical help right away to avoid lasting damage to your penis
Color vision changes, such as seeing a blue tinge to objects or having difficulty telling the difference between the colors blue and green
In rare instances, men taking PDE5 inhibitors (oral erectile dysfunction medicines, including LEVITRA) reported a sudden decrease or loss of vision in one or both eyes or a sudden decrease or loss in hearing, sometimes with ringing in the ears and dizziness. It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors. If you experience sudden decrease or loss of vision or hearing, stop taking LEVITRA and contact a doctor right away.

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