Omeprazole and Sodium Bicarbonate

FULL PRESCRIBING INFORMATION

Indications and Usage for Omeprazole and Sodium Bicarbonate

Duodenal Ulcer

Omeprazole/Sodium Bicarbonate is indicated for short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. [See Clinical Studies (14.1)]

Gastric Ulcer

Omeprazole/Sodium Bicarbonate is indicated for short-term treatment (4-8 weeks) of active benign gastric ulcer. [See Clinical Studies (14.2)]

Treatment of Gastroesophageal Reflux Disease (GERD)

Symptomatic GERD

Omeprazole/Sodium Bicarbonate is indicated for the treatment of heartburn and other symptoms associated with GERD. [See Clinical Studies (14.3)]

Erosive Esophagitis

Omeprazole/Sodium Bicarbonate is indicated for the short-term treatment (4-8 weeks) of erosive esophagitis which has been diagnosed by endoscopy.

The efficacy of Omeprazole/Sodium Bicarbonate used for longer than 8 weeks in these patients has not been established. If a patient does not respond to 8 weeks of treatment, it may be helpful to give up to an additional 4 weeks of treatment. If there is recurrence of erosive esophagitis or GERD symptoms (e.g., heartburn), additional 4-8 week courses of Omeprazole/Sodium Bicarbonate may be considered. [See Clinical Studies (14.3)]

Maintenance of Healing of Erosive Esophagitis

Omeprazole/Sodium Bicarbonate is indicated to maintain healing of erosive esophagitis. Controlled studies do not extend beyond 12 months. [See Clinical Studies (14.4)]

Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients (40mg oral suspension only)

Omeprazole/Sodium Bicarbonate Powder for Oral Suspension 40 mg/1680 mg is indicated for the reduction of risk of upper GI bleeding in critically ill patients. [See CLINICAL STUDIES, Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients (14.5)]

Omeprazole and Sodium Bicarbonate Dosage and Administration

Omeprazole/Sodium Bicarbonate is available as a capsule and as a powder for oral suspension in 20 mg and 40 mg strengths of omeprazole for adult use. Directions for use for each indication are summarized in Table 1. All recommended doses throughout the labeling are based upon omeprazole.

Since both the 20 mg and 40 mg oral suspension packets contain the same amount of sodium bicarbonate (1680 mg), two packets of 20 mg are not equivalent to one packet of Omeprazole/Sodium Bicarbonate 40 mg; therefore, two 20 mg packets of Omeprazole/Sodium Bicarbonate should not be substituted for one packet of Omeprazole/Sodium Bicarbonate 40 mg.

Since both the 20 mg and 40 mg capsules contain the same amount of sodium bicarbonate (1100 mg), two capsules of 20 mg are not equivalent to one capsule of Omeprazole/Sodium Bicarbonate 40 mg; therefore, two 20 mg capsules of Omeprazole/Sodium Bicarbonate should not be substituted for one capsule of Omeprazole/Sodium Bicarbonate 40 mg.

Omeprazole/Sodium Bicarbonate should be taken on an empty stomach at least one hour before a meal.

For patients receiving continuous Nasogastric (NG)/ Orogastric (OG) tube feeding, enteral feeding should be suspended approximately 3 hours before and 1 hour after administration of Omeprazole/Sodium Bicarbonate Powder for Oral Suspension.

Table 1: Recommended Doses of Omeprazole/Sodium Bicarbonate by Indication for Adults 18 Years and Older

* Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy. [See Clinical Studies (14.1)]
** For additional information, [See Clinical Studies (14)]
+ For additional information, [See Indications and Usage (1)]
Indication	Recommended Dose	Frequency
Short-Term Treatment of Active Duodenal Ulcer	20 mg	Once daily for 4 weeks*,+
Benign Gastric Ulcer	40 mg	Once daily for 4-8 weeks **,+
Gastroesophageal Reflux Disease (GERD)
Symptomatic GERD (with no esophageal erosions)	20 mg	Once daily for up to 4 weeks+
Erosive Esophagitis	20 mg	Once daily for 4-8 weeks+
Maintenance of Healing of Erosive Esophagitis	20 mg	Once daily**
Reduction of Risk of Upper Gastrointestinal Bleeding in Critically Ill Patients (40 mg oral suspension only)	40 mg	40 mg initially followed by 40mg 6-8 hours later and 40mg daily thereafter for 14 days**

Special Populations

Hepatic Insufficiency

Consider dose reduction, particularly for maintenance of healing of erosive esophagitis. [See Clinical Pharmacology (12.3)]

Administration of Capsules

Omeprazole/Sodium Bicarbonate Capsules should be swallowed intact with water. DO NOT USE OTHER LIQUIDS. DO NOT OPEN CAPSULE AND SPRINKLE CONTENTS INTO FOOD.

Preparation and Administration of Suspension

Directions for use: Empty packet contents into a small cup containing 1-2 tablespoons of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and drink immediately. Refill cup with water and drink.

If Omeprazole/Sodium Bicarbonate is to be administered through a nasogastric (NG) or orogastric (OG) tube, the suspension should be constituted with approximately 20 mL of water. DO NOT USE OTHER LIQUIDS OR FOODS. Stir well and administer immediately. An appropriately-sized syringe should be used to instill the suspension in the tube. The suspension should be washed through the tube with 20 mL of water.

Use with clopidogrel

Avoid concomitant use of clopidogrel and omeprazole. Coadministration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see Warnings and Precautions (5.6) and Drug Interactions (7)].

Dosage Forms and Strengths

Omeprazole/Sodium Bicarbonate 20-mg Capsules: Each opaque, hard gelatin, white capsule, imprinted with the Santarus logo and “20”, contains 20 mg omeprazole and 1100 mg sodium bicarbonate.

Omeprazole/Sodium Bicarbonate 40-mg Capsules: Each opaque, hard gelatin, colored dark blue and white capsule, imprinted with the Santarus logo and “40”, contains 40 mg omeprazole and 1100 mg sodium bicarbonate.

Omeprazole/Sodium Bicarbonate Powder for Oral Suspension is a white, flavored powder packaged in unit-dose packets. Each packet contains either 20 mg or 40 mg omeprazole and 1680 mg sodium bicarbonate.

Contraindications

Omeprazole/Sodium Bicarbonate is contraindicated in patients with known hypersensitivity to any components of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, and urticaria.

Warnings and Precautions

Concomitant Gastric Malignancy

Symptomatic response to therapy with omeprazole does not preclude the presence of gastric malignancy.

Atrophic gastritis

Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole.

Buffer Content

Each Omeprazole/Sodium Bicarbonate Capsule contains 1100 mg (13 mEq) of sodium bicarbonate. The total content of sodium in each capsule is 304 mg.

Each packet of Omeprazole/Sodium Bicarbonate Powder for Oral Suspension contains 1680 mg (20 mEq) of sodium bicarbonate (equivalent to 460 mg of Na+).

The sodium content of Omeprazole/Sodium Bicarbonate products should be taken into consideration when administering to patients on a sodium restricted diet.

Because Omeprazole/Sodium Bicarbonate products contain sodium bicarbonate, they should be used with caution in patients with Bartter's syndrome, hypokalemia, hypocalcemia, and problems with acid-base balance. Long-term administration of bicarbonate with calcium or milk can cause milk-alkali syndrome.

Chronic use of sodium bicarbonate may lead to systemic alkalosis and increased sodium intake can produce edema and weight increase.

Bone Fracture

Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to the established treatment guidelines. [See Dosage and Administration (2) and Adverse Reactions (6.2)]

Diminished Anti-platelet Activity of clopidogrel due to Impaired CYP2C19 Function by Omeprazole

Clopidogrel is a prodrug. Inhibition of platelet aggregation by clopidogrel is entirely due to an active metabolite. The metabolism of clopidogrel to its active metabolite can be impaired by use with concomitant medications, such as omeprazole, that interfere with CYP2C19 activity. Avoid concomitant use of clopidogrel and omeprazole. Co-administration of clopidogrel with 80 mg omeprazole, a proton pump inhibitor that is an inhibitor of CYP2C19, reduces the pharmacological activity of clopidogrel if given concomitantly or if given 12 hours apart [see Drug Interactions (7)].

Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI.

For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), health care professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically. [See Adverse Reactions (6.2)]

Adverse Reactions

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

In the U.S. clinical trial population of 465 patients, the adverse reactions summarized in Table 2 were reported to occur in 1% or more of patients on therapy with omeprazole. Numbers in parentheses indicate percentages of the adverse reactions considered by investigators as possibly, probably or definitely related to the drug.

Table 2: Adverse Reactions Occurring In 1% or More of Patients on Omeprazole Therapy

	Omeprazole (n = 465)	Placebo (n = 64)	Ranitidine (n = 195)
Headache	6.9 (2.4)	6.3	7.7 (2.6)
Diarrhea	3.0 (1.9)	3.1 (1.6)	2.1 (0.5)
Abdominal Pain	2.4 (0.4)	3.1	2.1
Nausea	2.2 (0.9)	3.1	4.1 (0.5)
URI	1.9	1.6	2.6
Dizziness	1.5 (0.6)	0.0	2.6 (1.0)
Vomiting	1.5 (0.4)	4.7	1.5 (0.5)
Rash	1.5 (1.1)	0.0	0.0
Constipation	1.1 (0.9)	0.0	0.0
Cough	1.1	0.0	1.5
Asthenia	1.1 (0.2)	1.6 (1.6)	1.5 (1.0)
Back Pain	1.1	0.0	0.5

Table 3 summarizes the adverse reactions that occurred in 1% or more of omeprazole-treated patients from international double-blind, and open-label clinical trials in which 2,631 patients and subjects received omeprazole.

Table 3: Incidence of Adverse Reactions ≥ 1% Causal Relationship not Assessed

	Omeprazole (n = 2631)	Placebo (n = 120)
Body as a Whole, site unspecified
Abdominal pain	5.2	3.3
Asthenia	1.3	0.8
Digestive System
Constipation	1.5	0.8
Diarrhea	3.7	2.5
Flatulence	2.7	5.8
Nausea	4.0	6.7
Vomiting	3.2	10.0
Acid regurgitation	1.9	3.3
Nervous System/Psychiatric
Headache	2.9	2.5

A controlled clinical trial was conducted in 359 critically ill patients, comparing Omeprazole/Sodium Bicarbonate 40 mg/1680 mg suspension once daily to I.V. cimetidine 1200 mg/day for up to 14 days. The incidence and total number of AEs experienced by ≥ 3% of patients in either group are presented in Table 4 by body system and preferred term.

Table 4: Number (%) of Critically Ill Patients with Frequently Occurring (≥ 3%) Adverse Events by Body System and Preferred Term

* Clinically significant upper gastrointestinal bleeding was considered a serious adverse event but it is not included in this table.
NOS = Not otherwise specified.
	Omeprazole/Sodium Bicarbonate (N=178)	Cimetidine (N=181)
MedDRA Body System      Preferred Term	All AEs n (%)	All AEs n (%)
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Anemia NOS	14 (7.9)	14 (7.7)
Anemia NOS Aggravated	4 (2.2)	7 (3.9)
Thrombocytopenia	18 (10.1)	11 (6.1)
CARDIAC DISORDERS
Atrial Fibrillation	11 (6.2)	7 (3.9)
Bradycardia NOS	7 (3.9)	5 (2.8)
Supraventricular Tachycardia	6 (3.4)	2 (1.1)
Tachycardia NOS	6 (3.4)	6 (3.3)
Ventricular Tachycardia	8 (4.5)	6 (3.3)
GASTROINTESTINAL DISORDERS *
Constipation	8 (4.5)	8 (4.4)
Diarrhea NOS	7 (3.9)	15 (8.3)
Gastric Hypomotility	3 (1.7)	6 (3.3)
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Hyperpyrexia	8 (4.5)	3 (1.7)
Edema NOS	5 (2.8)	11 (6.1)
Pyrexia	36 (20.2)	29 (16.0)
INFECTIONS AND INFESTATIONS
Candidal Infection NOS	3 (1.7)	7 (3.9)
Oral Candidiasis	7 (3.9)	1 (0.6)
Sepsis NOS	9 (5.1)	9 (5.0)
Urinary Tract Infection NOS	4 (2.2)	6 (3.3)
INVESTIGATIONS
Liver Function Tests NOS
Abnormal	3 (1.7)	6 (3.3)
METABOLISM AND NUTRITION DISORDERS
Fluid Overload	9 (5.1)	14 (7.7)
Hyperglycaemia NOS	19 (10.7)	21 (11.6)
Hyperkalaemia	4 (2.2)	6 (3.3)
Hypernatraemia	3 (1.7)	9 (5.0)
Hypocalcaemia	11 (6.2)	10 (5.5)
Hypoglycaemia NOS	6 (3.4)	8 (4.4)
Hypokalaemia	22 (12.4)	24 (13.3)
Hypomagnesaemia	18 (10.1)	18 (9.9)
Hyponatraemia	7 (3.9)	5 (2.8)
Hypophosphataemia	11 (6.2)	7 (3.9)
PSYCHIATRIC DISORDERS
Agitation	6 (3.4)	16 (8.8)
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Acute Respiratory Distress Syndrome	6 (3.4)	7 (3.9)
Nosocomial Pneumonia	20 (11.2)	17 (9.4)
Pneumothorax NOS	1 (0.6)	8 (4.4)
Respiratory Failure	3 (1.7)	6 (3.3)
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Decubitus Ulcer	6 (3.4)	5 (2.8)
Rash NOS	10 (5.6)	11 (6.1)
VASCULAR DISORDERS
Hypertension NOS	14 (7.9)	6 (3.3)
Hypotension NOS	17 (9.6)	12 (6.6)

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of omeprazole. Because these reactions are voluntarily reported from a population of uncertain size, it is not always possible to reliably estimate their actual frequency or establish a causal relationship to drug exposure.

Body as a Whole: Hypersensitivity reactions, including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, interstitial nephritis, urticaria (see also Skin below), fever, pain, fatigue, malaise.

Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitation, elevated blood pressure, and peripheral edema.

Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, flatulence, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, dry mouth, stomatitis and abdominal swelling. During treatment with omeprazole, gastric fundic gland polyps have been noted rarely. These polyps are benign and appear to be reversible when treatment is discontinued. Gastroduodenal carcinoids have been reported in patients with Zollinger-Ellison syndrome on long term treatment with omeprazole. This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors.

Hepatic: Mild and, rarely, marked elevations of liver function tests [ALT (SGPT), AST (SGOT), γ-glutamyl transpeptidase, alkaline phosphatase, and bilirubin (jaundice)]. In rare instances, overt liver disease has occurred, including hepatocellular, cholestatic, or mixed hepatitis, liver necrosis (some fatal), hepatic failure (some fatal), and hepatic encephalopathy.

Metabolism and Nutritional Disorders: Hyponatremia, hypoglycemia, hypomagnesemia and weight gain.

Musculoskeletal: Muscle cramps, myalgia, muscle weakness, joint pain, bone fracture, and leg pain.

Nervous System/Psychiatric: Psychic disturbances including depression, agitation, aggression, hallucinations, confusion, insomnia, nervousness, tremors, apathy, somnolence, anxiety, dream abnormalities; vertigo; paresthesia; and hemifacial dysesthesia.

Respiratory: Epistaxis, pharyngeal pain.

Skin: Severe generalized skin reactions including toxic epidermal necrolysis (TEN; some fatal), Stevens-Johnson syndrome, and erythema multiforme (some severe); purpura and/or petechiae (some with rechallenge); skin inflammation, urticaria, angioedema, pruritus, photosensitivity, alopecia, dry skin, and hyperhidrosis.

Special Senses: Tinnitus, taste perversion.

Ocular: Blurred vision, ocular irritation, dry eye syndrome, optic atrophy, anterior ischemic optic neuropathy, optic neuritis and double vision.

Urogenital: Interstitial nephritis (some with positive rechallenge), urinary tract infection, microscopic pyuria, urinary frequency, elevated serum creatinine, proteinuria, hematuria, glycosuria, testicular pain, and gynecomastia.

Hematologic: Rare instances of pancytopenia, agranulocytosis (some fatal), thrombocytopenia, neutropenia, leukopenia, anemia, leucocytosis, and hemolytic anemia have been reported.

The incidence of clinical adverse experiences in patients greater than 65 years of age was similar to that in patients 65 years of age or less.

Additional adverse reactions that could be caused by sodium bicarbonate include metabolic alkalosis, seizures, and tetany.

Drug Interactions

Drugs for which gastric pH can affect bioavailability

Because of its inhibition of gastric acid secretion, it is theoretically possible that omeprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (e.g., ketoconazole, ampicillin esters, iron salts, and digoxin). In the clinical efficacy trials, antacids were used concomitantly with the administration of omeprazole.

Drugs metabolized by cytochrome P450 (CYP)

Omeprazole can prolong the elimination of diazepam, warfarin and phenytoin, drugs that are metabolized by oxidation in the liver. There have been reports of increased INR and prothrombin time in patients receiving proton pump inhibitors, including omeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Patients treated with proton pump inhibitors and warfarin may need to be monitored for increases in INR and prothrombin time.

Although in normal subjects no interaction with theophylline or propranolol was found, there have been clinical reports of interaction with other drugs metabolized via the cytochrome P-450 system (e.g., cyclosporine, disulfiram, benzodiazepines). Patients should be monitored to determine if it is necessary to adjust the dosage of these drugs when taken concomitantly with Omeprazole/Sodium Bicarbonate.

Concomitant administration of omeprazole and voriconazole (a combined inhibitor of CYP2C19 and CYP3A4) resulted in more than doubling of the omeprazole exposure. Dose adjustment of omeprazole is not normally required.. When voriconazole (400 mg every 12 hours for one day, then 200 mg for 6 days) was given with omeprazole (40 mg once daily for 7 days) to healthy subjects, it significantly increased the steady-state Cmax and AUC0-24 of omeprazole, an average of 2 times (90% CI: 1.8, 2.6) and 4 times (90% CI: 3.3, 4.4) respectively as compared to when omeprazole was given without voriconazole.

Antiretroviral Agents

Concomitant administration of atazanavir and proton pump inhibitors is not recommended. Co-administration of atazanavir with proton pump inhibitors is expected to substantially decrease atazanavir plasma concentrations and thereby reduce its therapeutic effect.

Omeprazole has been reported to interact with some antiretroviral drugs. The clinical importance and the mechanisms behind these interactions are not always known. Increased gastric pH during omeprazole treatment may change the absorption of the antiretroviral drug. Other possible interaction mechanisms are via CYP2C19. For some antiretroviral drugs, such as atazanavir and nelfinavir, decreased serum levels have been reported when given together with omeprazole. Following multiple doses of nelfinavir (1250 mg, twice daily) and omeprazole (40 mg, daily), AUC was decreased by 36% and 92%, Cmax by 37% and 89% and Cmin by 39% and 75% respectively for nelfinavir and M8. Following multiple doses of atazanavir (400 mg, daily) and omeprazole (40 mg, daily, 2 hours before atazanavir), AUC was decreased by 94%, Cmax by 96%, and Cmin by 95%. Concomitant administration with omeprazole and drugs such as atazanavir and nelfinavir is therefore not recommended. For other antiretroviral drugs, such as saquinavir, elevated serum levels have been reported with an increase in AUC by 82%, in Cmax by 75% and in Cmin by 106% following multiple dosing of saquinavir/ritonavir (1000/100 mg) twice daily for 15 days with omeprazole 40 mg daily co-administered days 11 to 15. Dose reduction of saquinavir should be considered from the safety perspective for individual patients. There are also some antiretroviral drugs of which unchanged serum levels have been reported when given with omeprazole.

Antimicrobials

Omeprazole 40 mg daily was given in combination with clarithromycin 500 mg every 8 hours to healthy adult male subjects. The steady state plasma concentrations of omeprazole were increased (Cmax, AUC0-24, and T1/2 increases of 30%, 89% and 34% respectively) by the concomitant administration of clarithromycin. The observed increases in omeprazole plasma concentration were associated with the following pharmacological effects. The mean 24-hour gastric pH value was 5.2 when omeprazole was administered alone and 5.7 when co-administered with clarithromycin.

The plasma levels of clarithromycin and 14-hydroxyclarithromycin were increased by the concomitant administration of omeprazole. For clarithromycin, the mean Cmax was 10% greater, the mean Cmin was 27% greater, and the mean AUC0-8 was 15% greater when clarithromycin was administered with omeprazole than when clarithromycin was administered alone. Similar results were seen for 14-hydroxyclarithromycin, the mean Cmax was 45% greater, the mean Cmin was 57% greater, and the mean AUC0-8 was 45% greater. Clarithromycin concentrations in the gastric tissue and mucus were also increased by concomitant administration of omeprazole.

Table 5: Clarithromycin Tissue Concentrations 2 hours after Dose1

Tissue	Clarithromycin	Clarithromycin + Omeprazole
Antrum	10.48 ± 2.01 (n = 5)	19.96 ± 4.71 (n = 5)
Fundus	20.81 ± 7.64 (n = 5)	24.25 ± 6.37 (n = 5)
Mucus	4.15 ± 7.74 (n = 4)	39.29 ± 32.79 (n = 4)
	1Mean ± (μg/g)
	1Mean ± (μg/g)

Clopidogrel

Omeprazole is an inhibitor of CYP2C19 enzyme. Clopidogrel is metabolized to its active metabolite in part by CYP2C19. Concomitant use of omeprazole 80 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition [see Warnings and Precautions (5.6)].

In a crossover clinical study, 72 healthy subjects were administered clopidogrel (300 mg loading dose followed by 75 mg per day) alone and with omeprazole (80 mg at the same time as clopidogrel) for 5 days. The exposure to the active metabolite of clopidogrel was decreased by 46% (Day 1) and 42% (Day 5) when clopidogrel and omeprazole were administered together. The active metabolite of clopidogrel selectively and irreversibly inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor, thereby inhibiting platelet aggregation. The mean inhibition of platelet aggregation at 5 mcM ADP was diminished by 39% (Day 1) and 21% (Day 5) when clopidogrel and omeprazole were administered together.

In another study, 72 healthy subjects were given the same doses of clopidogrel and 80 mg omeprazole but the drugs were administered12 hours apart; the results were similar, indicating that administering clopidogrel and omeprazole at different times does not prevent their interaction [see Warnings and Precautions (5.6)].

There are no adequate combination studies of a lower dose of omeprazole or a higher dose of clopidogrel in comparison with the approved dose of clopidogrel.

Tacrolimus

Concomitant administration of omeprazole and tacrolimus may increase the serum levels of tacrolimus.

USE IN SPECIFIC POPULATIONS

Pregnancy

Pregnancy Category C

There are no adequate and well-controlled studies on the use of omeprazole in pregnant women. The vast majority of reported experience with omeprazole during human pregnancy is first trimester exposure and the duration of use is rarely specified, eg, intermittent versus chronic. An expert review of published data on experiences with omeprazole use during pregnancy by TERIS – the Teratogen Information System – concluded that therapeutic doses during pregnancy are unlikely to pose a substantial teratogenic risk (the quantity and quality of data were assessed as fair).1

Three epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy to the frequency of abnormalities among infants of women exposed to H2-receptor antagonists or other controls. A population-based prospective cohort epidemiological study from the Swedish Medical Birth Registry, covering approximately 99% of pregnancies, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy.2 In utero exposure to omeprazole was not associated with increased risk of any malformation (odds ratio 0.82, 95% CI 0.50-1.34), low birth weight or low Apgar score. The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole exposed infants than the expected number in the normal population. The author concluded that both effects may be random.

A retrospective cohort study reported on 689 pregnant women exposed to either H2-blockers or omeprazole in the first trimester (134 exposed to omeprazole).3 The overall malformation rate was 4.4% (95% CI 3.6-5.3) and the malformation rate for first trimester exposure to omeprazole was 3.6% (95% CI 1.5-8.1). The relative risk of malformations associated with first trimester exposure to omeprazole compared with nonexposed women was 0.9 (95% CI 0.3-2.2). The study could effectively rule out a relative risk greater than 2.5 for all malformations. Rates of preterm delivery or growth retardation did not differ between the groups.

A controlled prospective observational study followed 113 women exposed to omeprazole during pregnancy (89% first trimester exposures).4 The reported rates of major congenital malformations was 4% for the omeprazole group, 2% for controls exposed to nonteratogens, and 2.8% in disease-paired controls (background incidence of major malformations 1-5%). Rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight did not differ between the groups. The sample size in this study has 80% power to detect a 5-fold increase in the rate of major malformation.

Several studies have reported no apparent adverse short term effects on the infant when single dose oral or intravenous omeprazole was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia.

Reproduction studies conducted with omeprazole in rats at oral doses up to 28 times the human dose of 40 mg/day (based on body surface area) and in rabbits at doses up to 28 times the human dose (based on body surface area) did not show any evidence of teratogenicity. In pregnant rabbits, omeprazole at doses about 2.8 to 28 times the human dose of 40 mg/day, (based on body surface area) produced dose-related increases in embryo-lethality, fetal resorptions, and pregnancy loss. In rats treated with omeprazole at doses about 2.8 to

Macutek Smooth Dissolve Tablets

Pronunciation: bay-ta KAR-oh-teen/as-KORE-bik AS-id/VYE-ta-min E/ZINK/KOP-er/loo-TEE-in/ZEE-uh-ZAN-thin
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Brand Name: Macutek Smooth Dissolve Tablets

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How to use Macutek Smooth Dissolve Tablets:

Use Macutek Smooth Dissolve Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Place the tablet in your mouth and let it dissolve. The tablet dissolves quickly and can be swallowed with saliva. Macutek Smooth Dissolve Tablets may be taken with or without water.


• You may chew Macutek Smooth Dissolve Tablets if you desire.


• Take Macutek Smooth Dissolve Tablets by mouth with or without food.


• Take Macutek Smooth Dissolve Tablets on a regular schedule to get the most benefit from it. Taking Macutek Smooth Dissolve Tablets at the same time each day will help you remember to take it.


• If you miss a dose of Macutek Smooth Dissolve Tablets, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Macutek Smooth Dissolve Tablets.

Important safety information:

• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• Do not take large doses of vitamins (megadoses or megavitamin therapy) while you use Macutek Smooth Dissolve Tablets unless your doctor tells you to.


• Macutek Smooth Dissolve Tablets has many vitamins (beta carotene, vitamin C, vitamin E, zinc, copper, lutein, and zeaxanthin) in it. Before you start any new medicine, check the label to see if it has the same vitamins in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Macutek Smooth Dissolve Tablets while you are pregnant. It is not known if Macutek Smooth Dissolve Tablets is found in breast milk. If you are or will be breast-feeding while you use Macutek Smooth Dissolve Tablets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Macutek Smooth Dissolve Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea, nausea, stomach upset, or cramping; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Macutek Smooth Dissolve Tablets:

Store Macutek Smooth Dissolve Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store in original packaging until just before use. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Macutek Smooth Dissolve Tablets out of the reach of children and away from pets.

General information:

• If you have any questions about Macutek Smooth Dissolve Tablets, please talk with your doctor, pharmacist, or other health care provider.


• Macutek Smooth Dissolve Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Macutek Smooth Dissolve Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Macutek Smooth Dissolve Tablets resources

• Macutek Smooth Dissolve Tablets Use in Pregnancy & Breastfeeding
• Macutek Smooth Dissolve Tablets Drug Interactions
• Macutek Smooth Dissolve Tablets Support Group
• 4 Reviews for Macutek Smooth Dissolves - Add your own review/rating

Compare Macutek Smooth Dissolve Tablets with other medications

• Dietary Supplementation
• Hyperhomocysteinemia

Solomy

Solomy may be available in the countries listed below.

Ingredient matches for Solomy

Difluprednate

Difluprednate is reported as an ingredient of Solomy in the following countries:

• Japan

International Drug Name Search

levamisole

Generic Name: levamisole (leave AH mih sole)

Brand Names: Ergamisol

What is levamisole?

Levamisole is a cancer (antineoplastic) medication. Levamisole interferes with the growth of cancer cells and slows their growth and spread in the body.

Levamisole is used in the treatment of colon cancer.

Levamisole may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about levamisole?

Serious side effects have been reported with the use of levamisole including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function or blood problems (fever or chills; or signs of infection); nervous system problems (confusion or loss of consciousness, extreme fatigue, memory loss, muscle weakness, numbness or tingling; seizure, speech disturbances); and others. Talk to your doctor about the possible side effects from treatment with levamisole.

What should I discuss with my healthcare provider before taking levamisole?

Do not use levamisole without first talking to your doctor if you have

• liver disease;


• 
  

  a seizure disorder;

  
  


• 
  

  a bleeding or blood clotting disorder; or

  
  


• 
  

  poor bone marrow function.

  
  

The use of levamisole may be dangerous if you have any of the conditions listed above.

Levamisole is in the FDA pregnancy category C. This means that it is unknown whether it will be harmful to an unborn baby. Do not use levamisole without first talking to your doctor if you are pregnant or could become pregnant during treatment. Discuss with your doctor the appropriate use of birth control during treatment with levamisole if necessary. It is not known whether levamisole passes into breast milk. Do not take levamisole without first talking to your doctor if you are breast feeding a baby.

How should I use levamisole?

Take levamisole exactly as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose by mouth with a full glass of water.

Your doctor will determine the correct amount and frequency of treatment with levamisole depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor may want you to have blood tests and other medical evaluations during treatment with levamisole to monitor progress and side effects.

Your healthcare provider will store levamisole as directed by the manufacturer. If you are storing levamisole at home, follow the directions provided by your healthcare provider.

What happens if I miss a dose?

Contact your doctor if you miss a dose of levamisole.

What happens if I overdose?

If for any reason an overdose of levamisole is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a levamisole overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while using levamisole?

Levamisole can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with levamisole. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Alcohol should be avoided or used with caution while taking levamisole. Flushing, nausea, vomiting, headache, swelling, and rashes have occurred when alcohol has been used during treatment with levamisole.

Levamisole side effects

If you experience any of the following serious side effects from levamisole, seek emergency medical attention or contact your doctor immediately:

• 
  

  an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

  
  


• 
  

  decreased bone marrow function or blood problems (extreme fatigue; or fever, chills, or signs of infection); or

  
  


• 
  

  nervous system problems (confusion or loss of consciousness, extreme fatigue, memory loss, muscle weakness, numbness or tingling; seizure, speech disturbances).

  
  

Other, less serious side effects may be more likely to occur. Continue taking levamisole and talk to your doctor if you experience:

• 
  

  nausea, vomiting, or loss of appetite;

  
  


• 
  

  diarrhea;

  
  


• 
  

  sores in the mouth or on the lips; or

  
  


• 
  

  rash and itching.

  
  

Other side effects have also been reported. Discuss with your doctor any side effect that occurs during treatment with levamisole.

Levamisole Dosing Information

Usual Adult Dose for Malignant Disease:

50 mg orally every 8 hours for 3 days (starting 7-30 days post-surgery). May be given as maintenance therapy for 3 days at 2 week intervals for 1 year.

What other drugs will affect levamisole?

Before using levamisole, tell your doctor if you are taking any of the following:

• 
  

  phenytoin (Dilantin, others); or

  
  


• 
  

  warfarin (Coumadin).

  
  

You may not be able to take levamisole, or you may require a dosage adjustment or special monitoring during treatment if you are taking any of the medications listed above.

Do not receive "live" vaccines during treatment with levamisole. Administration of a live vaccine may be dangerous during treatment with levamisole.

Drugs other than those listed here may also interact with levamisole. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, during treatment with levamisole.

More levamisole resources

• Levamisole Side Effects (in more detail)
• Levamisole Dosage
• Levamisole Use in Pregnancy & Breastfeeding
• Levamisole Drug Interactions
• Levamisole Support Group
• 0 Reviews for Levamisole - Add your own review/rating

• levamisole Advanced Consumer (Micromedex) - Includes Dosage Information

Compare levamisole with other medications

• Cancer
• Rheumatoid Arthritis

Where can I get more information?

• Your healthcare provider may have additional information about levamisole that you may read.

What does my medication look like?

Levamisole is available with a prescription under the brand name Ergamisol. Other brand or generic formulations may also be available. Ask your healthcare provider or pharmacist any questions you have about this medication, especially if it is new to you.

See also: levamisole side effects (in more detail)

Fexofénadine Winthrop

Fexofénadine Winthrop may be available in the countries listed below.

Ingredient matches for Fexofénadine Winthrop

Fexofenadine

Fexofenadine hydrochloride (a derivative of Fexofenadine) is reported as an ingredient of Fexofénadine Winthrop in the following countries:

• France

International Drug Name Search

latanoprost Ophthalmic

la-TAN-oh-prost

Commonly used brand name(s)

In the U.S.

• Xalatan

Available Dosage Forms:

• Solution

Therapeutic Class: Antiglaucoma

Pharmacologic Class: Prostaglandin

Uses For latanoprost

Latanoprost is used to treat certain kinds of glaucoma. It is also used to treat a condition called hypertension of the eye. Latanoprost appears to work by increasing the outflow of fluid from the eye. This lowers the pressure in the eye.

latanoprost is available only with your doctor's prescription.

Before Using latanoprost

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For latanoprost, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to latanoprost or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on latanoprost have been done only in adult patients, and there is no specific information comparing use of latanoprost in children with use in other age groups.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of latanoprost in the elderly with use in other age groups, latanoprost has been used mostly in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of latanoprost. Make sure you tell your doctor if you have any other medical problems, especially:

• Eye disease, such as iritis or uveitis—Use of latanoprost may make the condition worse

• Eye problems, such as loss of the lens of the eye or


• Intraocular lens (IOL) replacement—May be more prone to an adverse reaction called macular edema

• Kidney disease or


• Liver disease—Higher blood levels of latanoprost may result, which may lead to increased side effects

Proper Use of latanoprost

Use latanoprost only as directed. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

If your doctor ordered two different eye drops to be used together, wait at least 5 minutes between the times you apply the medicines. This will help to keep the second medicine from “washing out” the first one.

It is important that your doctor check your eye pressure at regular visits to make certain that your glaucoma is being controlled.

Contact lenses should be removed before you use latanoprost. You should wait at least 15 minutes after using the eye drops before reinserting them.

To use the eye drops:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.


• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

Dosing

The dose of latanoprost will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of latanoprost. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic solution (eye drops) dosage form:
  
  • For glaucoma or hypertension of the eye:
    
    • Adults—Use one drop in the affected eye(s) once a day in the evening.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of latanoprost, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Before the bottle has been opened for the first time, store in the refrigerator. After the bottle has been opened, store at room temperature (up to 25 °C [77 °F]) for up to 6 weeks, or in the refrigerator.

Precautions While Using latanoprost

While you are using latanoprost, the iris (colored part) of your treated eye(s) may slowly become more brown in color. This is more likely to happen if you have blue-brown, gray-brown, green-brown, or yellow-brown eyes. The change in color of the iris is noticeable usually within several months or years from the start of treatment with latanoprost. In addition, there may be a darkening of eyelid skin color. Also, your eyelashes may become longer, thicker, and darker. These changes to the iris, eyelid, and lashes may be permanent even if you stop using latanoprost. Also, these changes to the iris, eyelid, and lashes will affect only the eye being treated with latanoprost. Therefore, if only one eye is being treated, only that eye may develop darker iris, eyelid, and eyelashes and other changes to the eyelashes, and you may have differently appearing eyes. Check with your doctor if you have any questions about this.

Latanoprost may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.

latanoprost Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

• Eyelid crusting, redness, swelling, discomfort, or pain

Rare

• Cough


• difficulty breathing


• noisy breathing


• redness of eye or inside of eyelid


• shortness of breath


• swelling of the eye


• tightness in chest


• wheezing

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Blurred vision, eye irritation, or tearing


• darkening of eyelid skin color


• increase in brown color in colored part of eye


• longer, thicker, and darker eyelashes

Less common

• Angina pectoris or other chest pain


• cold or flu symptoms


• eye pain


• pain in muscles, joints, or back


• skin rash

Rare

• Discharge from the eye


• double vision or other change in vision


• fever


• sensitivity of eye to light


• sore throat

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Burning of eye


• feeling of something in eye


• itching of eye


• stinging of eye

Less common

• Dryness of eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: latanoprost Ophthalmic side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More latanoprost Ophthalmic resources

• Latanoprost Ophthalmic Side Effects (in more detail)
• Latanoprost Ophthalmic Use in Pregnancy & Breastfeeding
• Latanoprost Ophthalmic Drug Interactions
• Latanoprost Ophthalmic Support Group
• 5 Reviews for Latanoprost Ophthalmic - Add your own review/rating

• Xalatan Prescribing Information (FDA)


• Xalatan Monograph (AHFS DI)


• Xalatan Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Xalatan Consumer Overview

Compare latanoprost Ophthalmic with other medications

• Glaucoma, Open Angle
• Intraocular Hypertension

Diclofenaco Mundogen

Diclofenaco Mundogen may be available in the countries listed below.

Ingredient matches for Diclofenaco Mundogen

Diclofenac

Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Diclofenaco Mundogen in the following countries:

• Spain

International Drug Name Search

mecasermin Subcutaneous

me-ka-SER-min

Commonly used brand name(s)

In the U.S.

• Increlex


• Iplex

Available Dosage Forms:

• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Uses For mecasermin

Mecasermin injection is a man-made version of insulin-like growth factor-1 (IGF-1) hormone. IGF-1 is produced in the liver and plays an important role in childhood growth. Mecasermin is used to replace IGF-1 in children who are severely lacking it in their bodies.

mecasermin is available only with your doctor's prescription.

Before Using mecasermin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For mecasermin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to mecasermin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of mecasermin injection in children younger than 2 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies have not been performed on the relationship of age to the effects of mecasermin injection in the geriatric population. Safety and efficacy have not been established.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of mecasermin. Make sure you tell your doctor if you have any other medical problems, especially:

• Closed epiphyses (e.g., growth centers in the bones show no more growth potential) or


• Neoplasia, active or suspected (e.g., cancerous or noncancerous tumor)—Should not be used in patients with these conditions.

• Diabetes or


• Enlarged tonsils or


• Head injury or


• Scoliosis (abnormally curved spine), or history of—Use with caution. May make these conditions worse.

• Hypothyroidism (underactive thyroid) or


• Nutrition deficiencies—These problems should be corrected first before starting treatment with mecasermin.

Proper Use of mecasermin

Your doctor will prescribe your child's exact dose and tell you how often it should be given. mecasermin is given as a shot under your child's skin. mecasermin must not be injected into a vein or muscle.

Some medicines given by injection may sometimes be given at home to patients who do not need to be in the hospital. If you are using mecasermin at home, your doctor will teach you how to prepare and inject the medicine. You will have a chance to practice preparing and injecting it. Be sure that you understand exactly how the medicine is to be prepared and injected.

It is important to read the patient information and instructions for use, if provided with your medicine, each time your prescription is filled.

mecasermin must be taken 20 minutes before or 20 minutes after a snack or meal. Never let your child skip a meal once your child received mecasermin.

Use a new needle and syringe each time you inject the medicine to your child.

It is important to follow any instructions from your doctor about the careful selection and rotation of injection sites (e.g., upper arms, thighs, buttocks, or abdomen) on your body. This will help to prevent skin problems.

Do not use the medicine if it looks cloudy or has particles in it.

Dosing

The dose of mecasermin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of mecasermin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form:
  
  • For treatment of growth failure caused by IGF-1 deficiency:
    
    • Children 2 years of age and older—Dose is based on body weight and must be determined by your doctor. The starting dose is 0.04 to 0.08 milligram (mg) per kg (0.018 to 0.036 mg per lb) of body weight injected under the skin two times a day. Your doctor may then increase the dose, if needed.
    
    
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of mecasermin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store in the refrigerator. Do not freeze.

You may keep the opened vial in the refrigerator. Use it within 30 days after opening. Throw away any unused medicine after 30 days. Do not freeze the solution and protect it from direct heat and light.

Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Precautions While Using mecasermin

Your doctor will need to check your child's progress at regular visits while your child is using mecasermin. Be sure to keep all appointments.

Talk with your doctor if you notice or the child feels that mecasermin is causing too much growth.

mecasermin may cause hypoglycemia (low blood sugar) with the following symptoms that you should be aware of: anxiety; blurred vision; chills; cold sweats; coma; confusion; cool, pale skin; depression; dizziness; fast heartbeat; headache; increased hunger; nausea; nervousness; nightmares; seizures; shakiness; slurred speech; or unusual tiredness or weakness. It is important to have a source of sugar such as orange juice, candy, soda, glucose gel, or milk, if these symptoms occur.

Learn what to do if your child's blood sugar gets too low. Teach family members and friends what they can do to help if the child has low blood sugar.

You should avoid participating in high risk activities, such as driving, within 2 to 3 hours after receiving the medicine, especially at the beginning of mecasermin treatment.

mecasermin may cause serious types of allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if your child has a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after your child receive the medicine.

mecasermin may enlarge your child's tonsils. Call your doctor right away if your child has swollen tonsils, snoring, trouble with breathing or swallowing, or fluid in the ear. Your doctor may want to check your child's tonsils regularly while using mecasermin.

mecasermin may cause a dislocation in the hip bone. Check with your doctor right away if your child has a limp or pain in the hip or knee.

mecasermin contains benzyl alcohol which may cause serious reactions (e.g., gasping syndrome) for a newborn or premature infant. Discuss this with your doctor if you are concerned.

Do not take other medicines unless thy have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

mecasermin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Anxiety


• bluish skin color of the fingertips


• blurred vision


• breathlessness


• chest pain


• chills


• cold sweats


• coma


• confusion


• cool, pale skin


• depression


• dizziness


• fast heartbeat


• headache


• increased hunger


• loss of hearing


• nausea


• nervousness


• nightmares


• rapid growth of normal cells of the thymus (no symptoms)


• seizures


• shakiness


• slurred speech


• thickening of the skin


• unusual tiredness or weakness

Incidence not known

• Change in the ability to see colors, especially blue or yellow


• cough


• difficult or labored breathing


• difficulty with swallowing


• hives or welts


• itching


• itching or hives at the injection site


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• limp


• pain in the hip or knee


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• redness of the skin


• shortness of breath


• skin rash


• tightness in the chest


• vomiting


• wheezing

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Anxiety


• arm or leg pain


• backache


• changes in vision


• excessive sweating


• extreme weakness


• frequent urination


• increase in hands and feet size


• increased thirst


• increased volume of pale, diluted urine


• joint pain


• stop in menstruation

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abnormal response of the tympanic membrane to air pressure


• difficulty with moving


• difficulty with swallowing


• ear pain


• earache


• large, flat, blue or purplish patches in the skin


• muffled hearing


• muscle pain or stiffness


• redness or swelling in the ear


• sense of fullness in the ear


• snoring


• sore throat


• voice changing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

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