DRUGS & SUPPLEMENTS

Hymin Plus

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Hymin Plus uses

Hymin Plus consists of Albendazole, Ivermectin.

Albendazole:


1 INDICATIONS AND USAGE

Hymin Plus is an anthelmintic drug indicated for:

  • Treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium. (1.1)
  • Treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus. (1.2)

1.1 Neurocysticercosis

Hymin Plus (Albendazole) is indicated for the treatment of parenchymal neurocysticercosis due to active lesions caused by larval forms of the pork tapeworm, Taenia solium.

1.2 Hydatid Disease

Hymin Plus (Albendazole) is indicated for the treatment of cystic hydatid disease of the liver, lung, and peritoneum, caused by the larval form of the dog tapeworm, Echinococcus granulosus.

2 DOSAGE AND ADMINISTRATION

Patients weighing 60 kg or greater, 400 mg twice daily; less than 60 kg, 15 mg/kg/day in divided doses twice daily. Hymin Plus (Albendazole) tablets and Hymin Plus (Albendazole) chewable tablets should be taken with food. (2)

  • Hydatid disease: 28-day cycle followed by 14-day albendazole-free interval for a total of 3 cycles. (2)
  • Neurocysticercosis: 8 to 30 days. (2)

See additional important information in the Full Prescribing Information. (2)

2.1 Dosage

Dosing of Hymin Plus (Albendazole) will vary depending upon the indication. Hymin Plus (Albendazole) tablets may be crushed or chewed and swallowed with a drink of water. Hymin Plus (Albendazole) chewable tablets are also available for children and patients who may experience swallowing difficulties. Hymin Plus (Albendazole) tablets and Hymin Plus (Albendazole) chewable tablets should be taken with food [see Clinical Pharmacology (12.3)].

Indication Patient Weight Dose Duration
Hydatid Disease 60 kg or greater 400 mg twice daily, with meals 28-day cycle followed by a 14-day albendazole-free interval, for a total of 3 cycles
Less than 60 kg 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg)
Neurocysticercosis 60 kg or greater 400 mg twice daily, with meals 8 to 30 days
Less than 60 kg 15 mg/kg/day given in divided doses twice daily with meals (maximum total daily dose 800 mg)

2.2 Concomitant Medication to Avoid Adverse Reactions

Patients being treated for neurocysticercosis should receive appropriate steroid and anticonvulsant therapy as required. Oral or intravenous corticosteroids should be considered to prevent cerebral hypertensive episodes during the first week of treatment [see Warnings and Precautions ].

2.3 Monitoring for Safety Before and During Treatment

  • Monitor blood counts at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with Hymin Plus (Albendazole) in all patients [see Warnings and Precautions (5.1)].
  • Monitor liver enzymes (transaminases) at the beginning of each 28-day cycle of therapy, and at least every 2 weeks during treatment with Hymin Plus (Albendazole) in all patients [see Warnings and Precautions (5.5)].
  • Obtain a pregnancy test in women of reproductive potential prior to therapy [see Warnings and Precautions (5.2)].
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3 DOSAGE FORMS AND STRENGTHS

  • Tablet: 200 mg
  • Chewable Tablet: 200 mg
  • Tablet: 200 mg (3)
  • Chewable Tablet: 200 mg (3)

4 CONTRAINDICATIONS

Hymin Plus (Albendazole) is contraindicated in patients with known hypersensitivity to the benzimidazole class of compounds or any components of Hymin Plus (Albendazole).

Patients with known hypersensitivity to the benzimidazole class of compounds or any components of Hymin Plus (Albendazole).

5 WARNINGS AND PRECAUTIONS

  • Bone Marrow Suppression: Fatalities have been reported due to bone marrow suppression; monitor blood counts in all patients at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy. Discontinue Hymin Plus if clinically significant changes in blood counts occur. (5.1, 5.4)
  • Teratogenic Effects: Obtain pregnancy test in women of reproductive potential prior to therapy and avoid usage in pregnant women except in clinical circumstances where no alternative management is appropriate. Discontinue therapy if pregnancy occurs and apprise patient of potential hazard to the fetus. (5.2)
  • Risk of Neurologic Symptoms: Neurocysticercosis patients may experience cerebral hypertensive episodes, seizures or focal neurologic deficits after initiation of therapy; begin appropriate steroid and anticonvulsant therapy. (5.3)
  • Risk of Retinal Damage in Retinal Cysticercosis: Cases of retinal involvement have been reported; examine the patient for the presence of retinal lesions before initiating therapy for neurocysticercosis. (5.4)
  • Hepatic Effects. Elevations of liver enzymes may occur. Monitor liver enzymes before the start of each treatment cycle and at least every 2 weeks while on Hymin Plus (Albendazole) therapy and discontinue if clinically significant elevations occur. (5.5)

5.1 Bone Marrow Suppression

Fatalities associated with the use of Hymin Plus (Albendazole) have been reported due to granulocytopenia or pancytopenia Hymin Plus (Albendazole) may cause bone marrow suppression, aplastic anemia, and agranulocytosis. Monitor blood counts at the beginning of each 28-day cycle of therapy, and every 2 weeks while on therapy with Hymin Plus (Albendazole) in all patients. Patients with liver disease and patients with hepatic echinococcosis are at increased risk for bone marrow suppression and warrant more frequent monitoring of blood counts. Discontinue Hymin Plus (Albendazole) if clinically significant decreases in blood cell counts occur.

5.2 Teratogenic Effects

Hymin Plus may cause fetal harm and should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. Obtain pregnancy test prior to prescribing Hymin Plus (Albendazole) to women of reproductive potential. Advise women of reproductive potential to use effective birth control for the duration of Hymin Plus (Albendazole) therapy and for one month after end of therapy. Immediately discontinue Hymin Plus (Albendazole) if a patient becomes pregnant and apprise the patient of the potential hazard to the fetus [see Use in Specific Populations (8.1)].

5.3 Risk of Neurologic Symptoms in Neurocysticercosis

Patients being treated for neurocysticercosis should receive steroid and anticonvulsant therapy to prevent neurological symptoms (e.g. seizures, increased intracranial pressure and focal signs) as a result of an inflammatory reaction caused by death of the parasite within the brain.

5.4 Risk of Retinal Damage in Patients with Retinal Neurocysticercosis

Cysticercosis may involve the retina. Before initiating therapy for neurocysticercosis, examine the patient for the presence of retinal lesions. If such lesions are visualized, weigh the need for anticysticeral therapy against the possibility of retinal damage resulting from inflammatory damage caused by ALBENZA-induced death of the parasite.

5.5 Hepatic Effects

In clinical trials, treatment with Hymin Plus has been associated with mild to moderate elevations of hepatic enzymes in approximately 16% of patients. These elevations have generally returned to normal upon discontinuation of therapy. There have also been case reports of acute liver failure of uncertain causality and hepatitis [see Adverse Reactions (6)].

Monitor liver enzymes (transaminases) before the start of each treatment cycle and at least every 2 weeks during treatment. If hepatic enzymes exceed twice the upper limit of normal, consideration should be given to discontinuing Hymin Plus (Albendazole) therapy based on individual patient circumstances. Restarting Hymin Plus (Albendazole) treatment in patients whose hepatic enzymes have normalized off treatment is an individual decision that should take into account the risk/benefit of further Hymin Plus (Albendazole) usage. Perform laboratory tests frequently if Hymin Plus (Albendazole) treatment is restarted.

Patients with elevated liver enzyme test results are at increased risk for hepatotoxicity and bone marrow suppression [see Warnings and Precautions (5.1)]. Discontinue therapy if liver enzymes are significantly increased or if clinically significant decreases in blood cell counts occur.

5.6 Unmasking of Neurocysticercosis in Hydatid Patients

Undiagnosed neurocysticercosis may be uncovered in patients treated with Hymin Plus (Albendazole) for other conditions. Patients with epidemiologic factors who are at risk for neurocysticercosis should be evaluated prior to initiation of therapy.

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6 ADVERSE REACTIONS

  • Adverse reactions 1% or greater in hydatid disease: abnormal liver function tests, abdominal pain, nausea/vomiting, reversible alopecia, headache, dizziness/vertigo, fever.
  • Adverse reactions 1% or greater in neurocysticercosis: headache, nausea/vomiting, raised intracranial pressure, meningeal signs. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Amedra Pharmaceuticals LLC at 1-888-894-6528 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1 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 practice.

The adverse reaction profile of Hymin Plus (Albendazole) differs between hydatid disease and neurocysticercosis. Adverse reactions occurring with a frequency of 1% or greater in either disease are described in Table 2 below.

These symptoms were usually mild and resolved without treatment. Treatment discontinuations were predominantly due to leukopenia (0.7%) or hepatic abnormalities (3.8% in hydatid disease). The following incidence reflects adverse reactions that were reported to be at least possibly or probably related to Hymin Plus (Albendazole).

Adverse Reaction Hydatid Disease Neurocysticercosis
Gastrointestinal
Abdominal Pain 6 0
Nausea 4 6
Vomiting 4 6
General disorders and administration site conditions
Fever 1 0
Investigations
Elevated Hepatic Enzymes 16 less than 1
Nervous system disorders
Dizziness 1 less than 1
Headache 1 11
Meningeal Signs 0 1
Raised Intracranial Pressure 0 2
Vertigo 1 less than 1
Skin and subcutaneous tissue disorders
Reversible Alopecia 2 less than 1

The following adverse events were observed at an incidence of less than 1%:

Blood and Lymphatic System Disorders: There have been reports of leukopenia, granulocytopenia, pancytopenia, agranulocytosis, or thrombocytopenia [see Warnings and Precautions (5.1)].

Immune System Disorders: Hypersensitivity reactions, including rash and urticaria.

6.2 Postmarketing Experience

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

Blood and Lymphatic System Disorders: Aplastic anemia, bone marrow suppression, neutropenia.

Eye Disorders: Vision blurred.

Gastrointestinal Disorders: Diarrhea.

General System Disorders: Asthenia.

Hepatobiliary Disorders: Elevations of hepatic enzymes, hepatitis, acute liver failure.

Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis.

Nervous System Disorders: Somnolence, convulsion.

Renal and Urinary Disorders: Acute renal failure.

Skin and Subcutaneous Tissue Disorders: Erythema multiforme, Stevens-Johnson syndrome.

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7 DRUG INTERACTIONS

  • Dexamethasone: Steady-state trough concentrations of Hymin Plus sulfoxide were about 56% higher when dexamethasone was coadministered with each dose of Hymin Plus (Albendazole). (7.1)
  • Praziquantel: In the fed state increased mean maximum plasma concentration and area under the curve of Hymin Plus (Albendazole) sulfoxide by about 50% in healthy subjects. (7.2)
  • Cimetidine: Increased Hymin Plus (Albendazole) sulfoxide concentrations in bile and cystic fluid by about 2-fold in hydatid cyst patients. (7.3)
  • Theophylline: Hymin Plus (Albendazole) induces cytochrome P450 1A in human hepatoma cells; therefore, it is recommended that plasma concentrations of theophylline be monitored during and after treatment. (5.5, 7.4)

7.1 Dexamethasone

Steady-state trough concentrations of Hymin Plus (Albendazole) sulfoxide were about 56% higher when 8 mg dexamethasone was co-administered with each dose of Hymin Plus (Albendazole) (15 mg/kg/day) in 8 neurocysticercosis patients.

7.2 Praziquantel

In the fed state, praziquantel increased mean maximum plasma concentration and area under the curve of Hymin Plus (Albendazole) sulfoxide by about 50% in healthy subjects (n = 10) compared with a separate group of subjects (n = 6) given Hymin Plus (Albendazole) alone. Mean Tmax and mean plasma elimination half-life of Hymin Plus (Albendazole) sulfoxide were unchanged. The pharmacokinetics of praziquantel were unchanged following co-administration with Hymin Plus (Albendazole) (400 mg).

7.3 Cimetidine

Hymin Plus (Albendazole) sulfoxide concentrations in bile and cystic fluid were increased (about 2-fold) in hydatid cyst patients treated with cimetidine (10 mg/kg/day) (n = 7) compared with Hymin Plus (Albendazole) (20 mg/kg/day) alone (n = 12). Hymin Plus (Albendazole) sulfoxide plasma concentrations were unchanged 4 hours after dosing.

7.4 Theophylline

Following a single dose of Hymin Plus (Albendazole) (400 mg), the pharmacokinetics of theophylline (aminophylline 5.8 mg/kg infused over 20 minutes) were unchanged. Hymin Plus (Albendazole) induces cytochrome P450 1A in human hepatoma cells; therefore, it is recommended that plasma concentrations of theophylline be monitored during and after treatment.

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Category C.

There are no adequate and well-controlled studies of Hymin Plus administration in pregnant women. Hymin Plus (Albendazole) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Hymin Plus (Albendazole) should not be used in pregnant women except in clinical circumstances where no alternative management is appropriate. Obtain pregnancy test prior to prescribing Hymin Plus (Albendazole) to women of reproductive potential. Advise women of reproductive potential to use effective birth control for the duration of Hymin Plus (Albendazole) therapy and for one month after end of therapy. If a patient becomes pregnant while taking this drug, Hymin Plus (Albendazole) should be discontinued immediately. If pregnancy occurs while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Hymin Plus (Albendazole) has been shown to be teratogenic (to cause embryotoxicity and skeletal malformations) in pregnant rats and rabbits. The teratogenic response in the rat was shown at oral doses of 10 and 30 mg/kg/day (0.10 times and 0.32 times the recommended human dose based on body surface area in mg/m2, respectively) during gestation days 6 to 15 and in pregnant rabbits at oral doses of 30 mg/kg/day (0.60 times the recommended human dose based on body surface area in mg/m2) administered during gestation days 7 to 19. In the rabbit study, maternal toxicity (33% mortality) was noted at 30 mg/kg/day. In mice, no teratogenic effects were observed at oral doses up to 30 mg/kg/day (0.16 times the recommended human dose based on body surface area in mg/m2), administered during gestation days 6 to 15.

8.3 Nursing Mothers

Hymin Plus (Albendazole) is excreted in animal milk. It is not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Hymin Plus (Albendazole) is administered to a nursing woman.

8.4 Pediatric Use

Hydatid disease is uncommon in infants and young children. In neurocysticercosis, the efficacy of Hymin Plus in children appears to be similar to that in adults.

8.5 Geriatric Use

In patients aged 65 and older with either hydatid disease or neurocysticercosis, there was insufficient data to determine whether the safety and effectiveness of Hymin Plus (Albendazole) is different from that of younger patients.

8.6 Patients with Impaired Renal Function

The pharmacokinetics of Hymin Plus in patients with impaired renal function has not been studied.

8.7 Patients with Extra-Hepatic Obstruction

In patients with evidence of extrahepatic obstruction (n = 5), the systemic availability of Hymin Plus (Albendazole) sulfoxide was increased, as indicated by a 2-fold increase in maximum serum concentration and a 7-fold increase in area under the curve. The rate of absorption/conversion and elimination of Hymin Plus (Albendazole) sulfoxide appeared to be prolonged with mean Tmax and serum elimination half-life values of 10 hours and 31.7 hours, respectively. Plasma concentrations of parent Hymin Plus (Albendazole) were measurable in only 1 of 5 patients.

10 OVERDOSAGE

In case of overdosage, symptomatic therapy and general supportive measures are recommended.

11 DESCRIPTION

Hymin Plus (Albendazole) (albendazole) is an orally administered anthelmintic drug. Chemically, it is methyl 5-(propylthio)-2-benzimidazolecarbamate. Its molecular formula is C12H15N3O2S. Its molecular weight is 265.34. It has the following chemical structure:

Hymin Plus (Albendazole) is a white to yellowish powder. It is freely soluble in anhydrous formic acid and very slightly soluble in ether and in methylene chloride. Hymin Plus (Albendazole) is practically insoluble in alcohol and in water.

Tablets

Each white to off-white, circular, biconvex, bevel-edged film coated, TILTAB tablet is debossed with “ap” and “550” and contains 200 mg of Hymin Plus (Albendazole).

Inactive ingredients consist of: carnauba wax, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium lauryl sulfate, sodium saccharin, sodium starch glycolate, and starch.

Chewable Tablets

Each round, mottled pink, concave chewable tablet is debossed with “ap” above “551” and contains 200 mg of Hymin Plus (Albendazole).

Inactive ingredients consist of: lactose monohydrate, microcrystalline cellulose, D-mannitol, sodium starch glycolate, povidone, N-C Wild Berry Type Flavor, magnesium stearate, crospovidone, polyvinyl acetate, sucralose, colloidal silicone dioxide, sodium lauryl sulfate, D&C Red #30/Helendon Pink Aluminum Lake.

methyl 5-(propylthio)-2-benzimidazolecarbamate

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Hymin Plus (albendazole) is a synthetic, antihelminthic drug of the class benzimidazole [see Clinical Pharmacology (12.4)].

12.3 Pharmacokinetics

Absorption

Hymin Plus (Albendazole) is poorly absorbed from the gastrointestinal tract due to its low aqueous solubility. Hymin Plus (Albendazole) concentrations are negligible or undetectable in plasma as it is rapidly converted to the sulfoxide metabolite prior to reaching the systemic circulation. The systemic anthelmintic activity has been attributed to the primary metabolite, Hymin Plus (Albendazole) sulfoxide. Oral bioavailability appears to be enhanced when Hymin Plus (Albendazole) is coadministered with a fatty meal (estimated fat content 40 grams) as evidenced by higher (up to 5-fold on average) plasma concentrations of Hymin Plus (Albendazole) sulfoxide as compared to the fasted state.

Maximal plasma concentrations of Hymin Plus (Albendazole) sulfoxide were achieved 2 hours to 5 hours after dosing and were on average 1310 ng/mL (range 460 ng/mL to 1580 ng/mL) following oral doses of Hymin Plus (Albendazole) (400 mg) in 6 hydatid disease patients, when administered with a fatty meal. Plasma concentrations of Hymin Plus (Albendazole) sulfoxide increased in a dose-proportional manner over the therapeutic dose range following ingestion of a high-fat meal (fat content 43.1 grams). The mean apparent terminal elimination half-life of Hymin Plus (Albendazole) sulfoxide ranged from 8 hours to 12 hours in 25 healthy subjects, as well as in 14 hydatid and 8 neurocysticercosis patients.

In a study conducted in 113 fed and 117 fasted healthy subjects, Hymin Plus (Albendazole) chewable tablets were bioequivalent to Hymin Plus (Albendazole) tablets following single 400 mg oral doses of Hymin Plus (Albendazole). In this study, the average time to reach the maximal plasma concentrations of Hymin Plus (Albendazole) sulfoxide was 4.5 hours (range 2 to 10 hours) with a fatty meal (fat content 60 grams) and at 3 hours (range 1 to 5 hours) in the fasted state. Following administration of Hymin Plus (Albendazole) chewable tablets, average maximal plasma concentrations of Hymin Plus (Albendazole) sulfoxide were 804 ng/mL (range 202 to 2244 ng/mL) and 218 ng/mL (range 54 to 592 ng/mL) in the fed and fasted states, respectively. The apparent elimination half-life of Hymin Plus (Albendazole) sulfoxide was comparable between Hymin Plus (Albendazole) chewable tablets and Hymin Plus (Albendazole) tablets when both were given either under fed or fasted conditions.

Following 4 weeks of treatment with Hymin Plus (Albendazole) (200 mg three times daily), 12 patients’ plasma concentrations of Hymin Plus (Albendazole) sulfoxide were approximately 20% lower than those observed during the first half of the treatment period, suggesting that Hymin Plus (Albendazole) may induce its own metabolism.

Distribution

Hymin Plus (Albendazole) sulfoxide is 70% bound to plasma protein and is widely distributed throughout the body; it has been detected in urine, bile, liver, cyst wall, cyst fluid, and cerebrospinal fluid (CSF). Concentrations in plasma were 3-fold to 10-fold and 2-fold to 4-fold higher than those simultaneously determined in cyst fluid and CSF, respectively.

Metabolism and Excretion

Hymin Plus (Albendazole) is rapidly converted in the liver to the primary metabolite, Hymin Plus (Albendazole) sulfoxide, which is further metabolized to Hymin Plus (Albendazole) sulfone and other primary oxidative metabolites that have been identified in human urine. Following oral administration, Hymin Plus (Albendazole) has not been detected in human urine. Urinary excretion of Hymin Plus (Albendazole) sulfoxide is a minor elimination pathway with less than 1% of the dose recovered in the urine. Biliary elimination presumably accounts for a portion of the elimination as evidenced by biliary concentrations of Hymin Plus (Albendazole) sulfoxide similar to those achieved in plasma.

Specific Populations

Pediatrics

Following single-dose administration of 200 mg to 300 mg (approximately 10 mg/kg) Hymin Plus (Albendazole) to 3 fasted and 2 fed pediatric patients with hydatid cyst disease (age range 6 to 13 years), Hymin Plus (Albendazole) sulfoxide pharmacokinetics were similar to those observed in fed adults.

Geriatrics

Although no studies have investigated the effect of age on Hymin Plus (Albendazole) sulfoxide pharmacokinetics, data in 26 hydatid cyst patients (up to 79 years) suggest pharmacokinetics similar to those in young healthy subjects.

12.4 Microbiology

Mechanism of Action

Hymin Plus (Albendazole) binds to the colchicine-sensitive site of β-tubulin inhibiting their polymerization into microtubules. The decrease in microtubules in the intestinal cells of the parasites decreases their absorptive function, especially the uptake of glucose by the adult and larval forms of the parasites, and also depletes glycogen storage. Insufficient glucose results in insufficient energy for the production of adenosine trisphosphate (ATP) and the parasite eventually dies.

Mechanism of Resistance

Parasitic resistance to Hymin Plus (Albendazole) is caused by changes in amino acids that result in changes in the β-tubulin protein. This causes reduced binding of the drug to β-tubulin.

In the specified treatment indications Hymin Plus (Albendazole) appears to be active against the larval forms of the following organisms:

Echinococcus granulosus

Taenia solium

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies were conducted in mice and rats.

No evidence of increased incidence of tumors was found in the mice or rats at up to 400 mg/kg/day or 20 mg/kg/day respectively (2 times and 0.2 times the recommended human dose on a body surface area basis).

In genotoxicity tests, Hymin Plus (Albendazole) was found negative in an Ames Salmonella/Microsome Plate mutation assay, Chinese Hamster Ovary chromosomal aberration test, and in vivo mouse micronucleus test. In the in vitro BALB/3T3 cells transformation assay, Hymin Plus (Albendazole) produced weak activity in the presence of metabolic activation while no activity was found in the absence of metabolic activation.

Hymin Plus (Albendazole) did not adversely affect male or female fertility in the rat at an oral dose of 30 mg/kg/day (0.32 times the recommended human dose based on body surface area in mg/m2).

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 How Supplied

Tablets

Each white to off-white, circular, biconvex, bevel-edged film coated, TILTAB tablet is debossed with “ap” and “550” and contains 200 mg of Hymin Plus.

Bottles of 2 Tablets NDC 52054-550-22

Bottles of 28 Tablets NDC 52054-550-28

Chewable Tablets

Each round, mottled pink, concave chewable tablet is debossed with “ap” above “551” and contains 200 mg of Hymin Plus (Albendazole).

2 Tablets in 1 Blister Pack (configured as a Wallet Card) NDC 52054-551-22

6 Tablets in 1 Blister Pack; 2 Blister Packs in 1 Carton NDC 52054-551-12

16.2 Storage and Handling

Store at 20° to 25°C (68° to 77°F).

17 PATIENT COUNSELING INFORMATION

Patients should be advised that:

  • Some people, particularly children, may experience difficulties swallowing the Hymin Plus (Albendazole) tablets whole. Hymin Plus (Albendazole) chewable tablet is available for children and patients who may be unable to swallow a tablet.
  • Take Hymin Plus (Albendazole) with food.
  • Hymin Plus (Albendazole) may cause fetal harm, therefore, obtain a pregnancy test in women of reproductive potential prior to initiating therapy.
  • Advise women of reproductive potential to use effective birth control while on Hymin Plus (Albendazole) and for one month after completing treatment.
  • During Hymin Plus (Albendazole) therapy, monitor blood counts and liver enzymes every 2 weeks because of the possibility of harm to the liver or bone marrow.

Hymin Plus (Albendazole) and TILTAB are registered trademarks of GlaxoSmithKline, used with permission.

Distributed by:

Amedra Pharmaceuticals LLC

Horsham, PA 19044

LB# 799-04

Hymin Plus (Albendazole) 2 count Hymin Plus (Albendazole) 28 count

Ivermectin:



Hymin Plus (Ivermectin)

(ivermectin)

POUR-ON for Cattle

Contains 5 MG ivermectin/mL

PARASITICIDE

Kills: Roundworms ( including Brown Stomach Worm), Lungworms, Grubs, Sucking Lice, Biting Lice, Mange Mites, Horn Files

NDC 13985-523-08

Restricted Drug (California) - Use Only as Directed

ANADA 200-318, Approved by FDA

WARNING! FLAMMABLE!

KEEP AWAY FROM HEAT,SPARKS,OPEN FLAME,

AND OTHER SOURCES OF IGNITION

WARNING! NOT FOR USE IN HUMANS

Net Contents: 169 fl oz (5 Liter)

Consult your veterinarian for assistance in the diagnosis, treatment and control of parasitism.

Introduction: Hymin Plus (Ivermectin) (ivermectin) Pour-On delivers internal and external parasite control in one

convenient low-volume application. Vetrimec Pour-On contains Hymin Plus (Ivermectin), a unique chemical

entity.

Indications: Hymin Plus (Ivermectin) (ivermectin) Pour-On applied at the recommended dose level of 500 mcg/kg is indicated for the effective treatment and control of these parasites.

Gastrointestinal Roundworms
Ostertagia ostertagi (adults and L4)
(including inhibited state)
Haemonchus placei (adults and L4)
Trichostrongylus axei (adults and L4)
T. colubriformis (adults and L4)
Cooperia oncophora (adults and L4)
Cooperia punctata (adults and L4)
Cooperia surnabada (adults and L4)
Strongyloides papillosus (adults)
Oesophagostomum radiatum (adults and L4)
Trichuris spp. (adults)
Lungworms
Dictyocaulus viviparus (adults and L4)
Cattle Grubs (parasitic stages)
Hypoderma bovis
H. lineatum
Mites
Sarcoptes scabiei var. bovis
Lice
Linognathus vituli
Haematopinus eurysternus
Damalinia bovis
Solenopotes capillatus
Horn Flies

Haematobia irritans


Persistent Activity: Hymin Plus (Ivermectin)TM (ivermectin) Pour-On has been proved to effectively control infections and to protect cattle from re-infection with: Oesophagostomum radiatum and Dictyocaulus viviparous for 28 days after treatment. Cooperia punctata and Trichostrongylus axei for 21 days after treatment; Ostertagia ostertagi, Haemonchus placei, Cooperia oncophora and Cooperia surnabada for 14 days after treatment; Damalinia bovis for 56 days after treatment.

Treatment of Cattle for Horn Flies: Hymin Plus (Ivermectin)TM (ivermectin) Pour-On controls horn flies (Haematobia irritans) for up to 28 days after dosing. For best results Hymin Plus (Ivermectin)TM (ivermectin) Pour-On should be part of a parasite control program for both internal and external parasites based on the epidemiology of these parasites. Consult your veterinarian or an entomologist for the most effective timing of applications.

Dosage: The dose rate is 1 mL for each 22 lb. of body weight. The formulation should be applied along the topline in a narrow strip extending from the withers to the tailhead.

Administration: Squeeze-Measure-Pour System (33.8 fl oz for 1 Liter Bottle with 25 mL Measuring Cap) Attach metering cap to the bottle.

Select the correct dose rate by rotating the adjuster cap in either direction to position the dose indicator to the appropriate dose.

Gently squeeze the bottle to fill to level (any excess will return to the bottle) and then tip and apply to animal along topline.

Back Pack (84.5 fl oz/2.5 Liter Pack and 169 fl oz/5 Liter Pack).

Connect the applicator gun to the backpack as follows: Attach the open end of the draw-off tubing to the dosing equipment. (Because of the solvents used in the formulation, only the Protector Drench Gun from Instrument Supplies Limited, or equivalent, is recommended. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage).

Replace the shipping cap with the draw-off cap and tighten down.

Attach draw-off tubing to the draw-off cap.

Gently prime the applicator gun, checking for leaks.

Follow the manufacturer's directions for adjusting the dose.

When the interval between use of the applicator gun is expected to exceed 12 hours, disconnect the gun and draw-off tubing from the product container and empty the product from the gun and tubing back into the product container. To prevent removal of special lubricants from the Protector Drench Gun, the gun and tubing must not be washed.

Free standing 338 fl oz/10 Liter Bottle

Connect the applicator gun to the 338 fl oz/10 L Bottle as follows: Attach the open end of the draw-off tubing to the dosing equipment. (Because of the solvents used in the formulation, only the Protector Drench Gun from Instrument Supply Limited, or equivalent is recommend. Other applicators may exhibit compatibility problems resulting in locking, incorrect dosage or leakage.)

Replace the shipping cap with the draw-off cap and tighten down.

Attach draw-off tubing to the draw-off cap.

Gently prime the applicator gun, checking for leaks.

Follow the manufacture's dirctions for adjusting the dose.

When the interval between uses of the applicator gun is expected to exceed 12 hours, disconnect the gun and draw-off tubing from the product container and empty the product from the gun and the tubing back into the product container. To prevent removal of special lubricants from the Protector Drench Gun, the gun and tubing must not be washed.

Mode of Action: Hymin Plus (Ivermectin) is a member of the macrocyclic lactone class of endectocides which have a uniques mode of action. Compounds of the class bind selectively and with high affinity to glutamate-gated chloride ion channels which occur in ivertebrate nerve and muscle cells. This leads to an increase in the permeability of the cell membrane to chloride ions with hyperpolarization of the nerve or muscle cell, resulting in paralysis and death of the parasite. Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA). The margin of safety for compounds of this class is attributable to the fact that mammals do not have the glutamate-gated chloride channel and they do not readily cross the blood-brain barrier.

Animal Safety: Studies conducted in the U.S.A. have demonstrated the safety margin for Hymin Plus (Ivermectin). Based on plasma levels, the topically applied formulation is expected to be at least as well tolerated by breeding animals as is the subcataneous formulation which had no effect on breeding performance.

RESIDUE WARNING: Cattle must not be treated within 48 days of slaughter for human consumption. Because of withdrawal time in milk has not been established, do not use in female dairy cattle of breeding age. A withdrawal period has not been established for this product in pre-ruminating calves. Do not use in calves to be processed for veal.

WARNING! NOT FOR USE IN HUMANS.

This product should not be applied to self or others because it may be irritating to human skin and eyes and absorbed through the skin. To minimize accidental skin contact, the user should wear a long-sleeved shirt and rubber gloves. If accidental skin contact occurs, wash immediately with soap and water. If accidental eye exposure occurs, flush eyes immediately with water and seek medical attention.

Keep this and all drugs out of reach of children.

Restricted Drug (California) - Use Only as Directed

The Material Safety Data Sheets (MSDS) contains more detailed occupational safety information. To report adverse effects, obtain an MSDS or for assistance contact Bimeda Inc. at 1-888-524-6332.

WARNING! FLAMMABLE!

KEEP AWAY FROM HEAT, SPARKS, OPEN

FLAME, AND OTHER SOURCES OF IGNITION.

PRECAUTIONS

Store at 20°C - 25°C (68°F-77°F), excursions permitted between 15°C and 30°C (between 59°F - 86°F). Brief exposure to temperature up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25"C (77°F); however such exposure should be minimized and protect from light.

Use only in well-ventilated areas or outdoors.

Close container tightly when not in use.

Cattle should not be treated when hair or hide is wet since reduced efficacy may be experienced.

Do not use when rain is expected to wet cattle within six hours after treatment.

This product is for application to skin surface only. Do not give orally or parenterally.

Cloudiness in the formulation may occur when Hymin Plus (Ivermectin) (ivermectin) Pour-On is stored at temperatures below 32°F. Allowing to warm at room temperature will restore the normal appearance without affecting efficacy.

Antiparasitic activity of Hymin Plus (Ivermectin) will be impaired if the formulation is applied to areas of the skin with mange scabs or lesions, or with dermatoses or adherent materials, e.g., caked mud or manure.

lvermectin has been associated with adverse reactions in sensitive dogs; therefore, Hymin Plus (Ivermectin) (ivermectin) Pour-On is not recommended for use in species other than cattle.

When to Treat Cattle with Grubs: Vetrimec (ivermectin) Pour-On effectively controls all stages of cattle grubs. However, proper timing of treatment is important. For the most effective results, cattle should be treated as soon as possible after the end of the heel fly (warble fly) season. While this is not peculiar to Hymin Plus (Ivermectin), destruction of Hypoderma larvae (cattle grubs) at the period when these grubs are in vital areas may cause undesirable host-parasite reactions. Killing Hypoderma lineatum when it is in the esophageal tissues may cause bloat; killing H. bovis when it is in the vertebral canal may cause staggering or paralysis. Cattle should be treated either before or after these stages of grub development.

Cattle treated with Hymin Plus (Ivermectin) (ivermectin) Pour-On at the end of the fly season may be re-treated with Hymin Plus (Ivermectin) (ivermectin) Pour-On during the winter without danger of grub-related reactions. For further information and advice on a planned parasite control program, consult your veterinarian.

Environmental Safety: Studies indicate that when Hymin Plus (Ivermectin) comes in contact with soil, it readily and tightly binds to the soil and becomes inactive over time. Free Hymin Plus (Ivermectin) may adversely affect fish or certain aquatic organisms. Do not permit cattle to enter lakes, streams, or ponds for at least 6 hours after treatment. Do not contaminate water by direct application or by the improper disposal of drug containers. Dispose of containers in an approved landfill or by incineration.

As with other avermectins, Hymin Plus (Ivermectin) is excreted in the dung of treated animals and can inhibit the reproduction and growth of pest and beneficial insects that use dung as a source of food and for reproduction. The magnitude and duration of such effects are species and life-cycle specific. When used according to label directions, the product is not expected to have an adverse impact on populations of dung-dependant insects.

Package lnformation: Hymin Plus (Ivermectin) (ivermectin) Pour-on is available in a 33.8 II oz/1 Liter Bottle with a measure-pour system, an 84.5 fl. oz/2.5 Liter Pack, a 169 fl. oz/5 Liter Pack, and a 338 fl oz/10 Liter Bottle intended for use with appropriate automatic dosing equipment.

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Hymin Plus pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Hymin Plus available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Hymin Plus destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Hymin Plus Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Hymin Plus pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


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References

  1. Dailymed."ALBENZA (ALBENDAZOLE) TABLET, FILM COATED ALBENZA (ALBENDAZOLE) TABLET, CHEWABLE [AMEDRA PHARMACEUTICALS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."VETRIMEC (IVERMECTIN) SOLUTION [MWI VETONE]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. Dailymed."ALBENDAZOLE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Hymin Plus?

Depending on the reaction of the Hymin Plus after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Hymin Plus not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Hymin Plus addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

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Review

sDrugs.com conducted a study on Hymin Plus, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Hymin Plus consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

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The information was verified by Dr. Arunabha Ray, MD Pharmacology

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