Selected Therapeutic Areas

Responding to patients‘ needs.

CHEPLAPHARM offers a diversified product portfolio. Please find below a number of prescription drugs of selected therapeutic areas.


ALCOHOL WITHDRAWAL

Alcohol is the most widely used and abused drug in the world, and alcohol use disorders lead to tremendous economic consequences for healthcare systems.  »

DISTRANEURIN® / HEMINEVRIN®

The active substance of the medicinal product is Clomethiazole, a short-acting hypnotic with sedative and anticonvulsant properties. According to several European guidelines, besides benzodiazepines, Clomethiazole is recommended as frontline-treatment concerning the therapy of acute alcohol withdrawal syndromes and delirium tremens. Additionally, DISTRANEURIN® / HEMINEVRIN® is also indicated in the management of restlessness and agitation in the elderly for clinical settings as well as in the treatment of severe insomnia if other therapies are not applicable. The product exhibits with its active substance Clomethiazole unique selling proposition on a global level.

OVERWEIGHT and OBESITY

Overweight and obesity are defined as abnormal or excessive fat accumulation caused by an imbalance between consumed and expended calories with a general impact on health condition. »

XENICAL®

XENICAL®, with its active substance orlistat, is a well-established medicinal product for the pharmacological treatment of overweight and obesity. It acts by the peripherally inhibition of gastrointestinal lipases. As a result the inactivated enzymes are unable to hydrolyze dietary triglycerides and, thus, the undigested triglycerides are not absorbed.
XENICAL® is indicated for treatment of obese or overweight patients (also for long-term obesity treatment) with associated co-morbidities, in conjunction with a mildly hypocaloric diet. Due to many years of clinical experience, the product has an established position in obesity treatment with positive benefit-risk profile and is first line therapy in addition to lifestyle interventions according to several national clinical practice guidelines. 

CARDIOVASCULAR DISEASES

Cardiovascular diseases summarize disorders affecting the heart and blood vessels including hypertension, coronary heart disease, congestive heart failure as well as cerebrovascular diseases.»

DILATREND® / CO-DILATREND® ǀ ALDACTONE® / ALDACTONE® - SALTUCIN® FORTE ǀ SOTALEX® ǀ INHIBACE®/Plus

DILATREND® contains the active substance carvedilol, which is a third generation, multiple action adrenergic receptor blocker with ß1-, ß1- and ß2-adrenergic receptor blockade properties and additional anti-inflammatory and anti-oxidative characteristics.
CO-DILATREND® further contains hydrochlorothiazide, that acts as diuretic by inhibition of the renal reabsorption of sodium and chloride. The active substance carvedilol is listed in the WHO list of essential medicines in the sections of antihypertensive medicines, medicines used in heart failure, antianginal medicines and antiarrhythmic medicines as well. According to many major clinical practice guidelines (e.g. United States, Europe, Australia), ß-blockers like carvedilol are first line therapy for the management of stable angina pectoris, additionally indicated as adjunctive therapy for the treatment of congestive heart failure and essential hypertension. 


ALDACTONE® contains as active substance spironolactone, which belongs to the pharmaceutical class of potassium-sparing diuretics. ALDACTONE® acts predominantly as a competitive antagonist of aldosterone leading to reduction of sodium reabsorption and potassium excretion by blocking the sodium-potassium exchange in the late distal tubules and collecting ducts of the kidney.
The combination product of ALDACTONE® - SALTUCIN® FORTE further contains the substance thiazide butizide. Butizide inhibits sodium reabsorption in the early renal distal tubules and, thus, increasing the diuretic effect of spironolactone. The active substance spironolactone is listed in the WHO list of essential medicines in the sections of medicines used in heart failure and diuretics as well.
With regard to the mode of action, ALDACTONE® is indicated in the treatment of primary and secondary hyperaldosteronism as well as edema due to hepatic cirrhosis, heart insufficiency or nephrotic syndrome, and respiratory insufficiency with chronic cor pulmonale. Furthermore, spironolactone is effective as add-on therapy in hypertension. 


SOTALEX® is a prescription drug indicated for the treatment of severe forms of ventricular tachyarrhytmia or atrial fibrillation, when other options are not tolerated. The unique selling proposition of Sotalol is its combined beta-blocker and anti-arrhythmic properties. Sotalol is a class III anti-arrhythmic agent that acts primarily by blocking the potassium channels and therefore can lead to prolongation of the action potential and QT interval. It is a well-established medicinal product with stable safety and efficacy profile. 


INHIBACE® is a classical angiotensin-converting enzyme (ACE) inhibitor with active substance cilazapril. It is indicated in the treatment of hypertension and chronic heart failure. INHIBACE® PLUS further contains the combination with hydrochlorothiazide and is indicated in the treatment of hypertension in patients not responding satisfactorily to each component administered alone. ACE inhibitors in combination with other anti-hypertensives like beta-blockers, calcium channel antagonists, angiotensin receptor blockers, diuretics, thiazides etc. are commonly used in clinical practice. According to clinical practice guidelines, ACE inhibitors are generally considered as first line therapy for hypertension. 

ANTIDOTE

For therapeutic purposes, antidotes are generally used in cases of poisoning, medication overdose or exposure to industrial or other toxicological agents to minimize or compensate the mostly life-threatening reactions. »

ANEXATE®

The active ingredient of ANEXATE® is Flumazenil. As benzodiazepine antagonist, ANEXATE® acts as an antidote to drugs of the benzodiazepine class and is used in clinical settings for reversal of benzodiazepine sedation/ overdose.

HEPATOBILIARY DISORDERS

Hepatobiliary disorders comprise a heterogeneous group of diseases that concern the liver and biliary system caused by a variety of factors. Important disorders belonging to the hepatobiliary system pose Cholelithiasis and Primary Biliary Cirrhosis (PBC). Cholelithiasis involves the presence of gallstones, which are concretions of bile components that form in the biliary tract and may often be associated with Acute Cholecystitis. »

DEURSIL® / DE-URSIL® / URSOLVAN® ǀ QUESTRAN®

The medicinal products DEURSIL® / DE-URSIL® / URSOLVAN® possess as common active ingredient Ursodeoxycholic acid (UDCA), a natural bile acid occurring only to a minor degree in human being. The products are used for treatment of several hepatic and biliary disorders, e.g. cholesterol gallstones. According to e.g. European clinical guidelines, the active substance UDCA is recommended as first line treatment of Primary Biliary Cirrhosis (PBC).


QUESTRAN® is a well-established medicinal product with CHOLESTYRAMINE as active substance belonging to the bile acid sequestrants. QUESTRAN® has several indications including reduction of serum cholesterol levels to prevent coronary heart disease, relief of pruritus associated with Partial Biliary Obstruction, adjunctive rehydration therapy to relieve diarrhoea due to bile acid malabsorption, and detoxification in case of chlordecone poisoning and phenprocoumon overdosage. All indications are authorised for both, adults and children. According to major clinical practice guidelines, CHOLESTYRAMINE is regarded as first line treatment for pruritus management related to Primary Biliary Obstruction as well as acute diarrhoea caused due to bile acid malabsorption. Furthermore, it represents a back-up lipid lowering agent for statin non-responder and is considered as second line/adjunctive therapy for hypercholesteremia.

VITAMIN K DEFICIENCY BLEEDING

Vitamin K plays an important role in coagulation due to its involvement in the formation of some clotting factors.»

KONAKION® MM /KONAKION® MM paediatric

KONAKION MM® is a well-established medicinal product with active substance Phytomenadione, a synthetic vitamin K1 that is included in the WHO list of essential medicines. It is indicated in the treatment of haemorrhage or risk of haemorrhage as a result of severe hypoprothrombinaemia of various etiologies (as antidote to anticoagulant of the Coumarin/Warfarin type, prophylaxis and treatment of vitamin K Deficiency Bleeding in the newborn). Phytomenadione is the first line therapy for reversal of anticoagulant, especially warfarin or coumarin type according to several major clinical practice guidelines. In many countries (including developing countries), vitamin K prophylaxis in neonates is recommended. 

VIROLOGY / PARASITOLOGY

Infectious disease remains one of the major causes of death worldwide associated with increasing treatment resistance and global spread due to globalization.»

CYMEVENE® ǀ FUNGIZONE® ǀ LARIAM®

CYMEVENE® is an antiviral medication containing Ganciclovir a nucleoside guanosine analogue, as active substance. It is indicated for the treatment and prevention of cytomegalovirus disease in immunocompromised patients and prevention of CMV disease in patients with drug-induced immunosuppression. Ganciclovir was the first antiviral agent approved for the treatment of cytomegalovirus disease and according to all major clinical practice guidelines, it remains the primary element in the therapy.


FUNGIZONE®, with its active substance amphotericin B, is a prescription-based anti-fungal medication. It is indicated for therapy of progressive, potentially severe fungal infections. Amphotericin B is included in the WHO list of essential medicines and represents an important component of anti-fungal therapy. According to several clinical guidelines, it is considered first line therapy for e.g. invasive mucormycosis infections, cryptococcal meningitis, and certain aspergillus and candidal infections. Intravenous formulation is also considered second line treatment option for American mucocutaneous leishmaniasis.


LARIAM®, with its active substance Mefloquine, is a prescription-based travel medicine. It is indicated especially for therapy of P. falciparum malaria in which the pathogen has become resistant to other antimalarial agents. Additionally, it is particularly recommended for travellers to malaria areas as part of chemoprophylaxis and has a well-established safety and efficacy profile. Mefloquine is included in the WHO list of essential medicines and represents an important component of anti-malarial therapy. 

MALIGNANT DISEASES

Cancer is a broad term for a large group of diseases that can affect any part of the body. The common characteristic of all cancer types and tumours is the uncontrolled growth of tumour cells that can displace and destroy healthy tissue. »

VESANOID® ǀ ETOPOPHOS® ǀ VEPESID®

VESANOID® contains as active ingredient Tretinoin, a natural derivative of vitamin A. According to international clinical guidelines, VESANOID® represents an obligate part in the treatment of Acute Promeylocytic Leukemia (APL). The introduction of Tretinoin (VESANOID®) in APL treatment has transformed this leukemia type from very fatal to highly curable. Therefore, the active ingredient Tretinoin was included in the WHO (World Health Organization) list of essential medicines and exhibits in Europe unique selling proposition.


ETOPOPHOS®, with its active substance etoposide phosphate, is a primary element of chemotherapy in certain cancer treatments like testicular tumour, small-cell lung cancer, acute non-lymphocytic leukemia, Hodgkin's lymphoma and malignant non-Hodgkin's lymphomas. It is often used in combination with other medicines. Etoposide phosphate represents a prodrug of the pharmacologically active drug 'etoposide' and is included in the WHO list of essential medicines.


VEPESID®, with its active substance etoposide, is a semisynthetic derivative of podophyllotoxin with anti-tumoral activity. It represents a primary element of chemotherapy in certain cancer treatments like testicular tumour, small-cell lung cancer, acute non-lymphocytic leukaemia, Hodgkin's lymphoma and malignant non-Hodgkin's lymphomas. Etoposide represents the pharmacologically active form of the prodrug 'etoposide phosphate' and is included in the WHO list of essential medicines.

RETINAL VASCULAR DISORDER

Retinal vascular disorders refer to a range of eye diseases that represent a major cause of blindness among all age groups. »

VISUDYNE®

VISUDYNE® is an anti-neovascularisation agent containing a benzoporphyrin derivative monoacid, verteporfin, as active substance. It is indicated in the treatment of (wet) age-related macular degeneration with classic subfoveal choroidal neovascularization or subfoveal choroidal neovascularization secondary to pathologic myopia. Due to its extensive evidence of safety and efficacy, it remains stable as the second line therapy in its approved indications, especially for patients who do not respond to the anti-VEGFs (approx. 10-15%). 

INSOMNIA

Insomnia is one of the most common sleep disorders characterized by difficulty falling and/or staying asleep with reduced quality, duration and restfulness of sleep. »

ROHYPNOL® | DORMICUM®

The worldwide marketed and well-established medicinal product ROHYPNOL® with its active ingredient Flunitrazepam belongs to the group of benzodiazepines. Benzodiazepines are centrally depressant psychotropic drugs with anxiolytic, anticonvulsant, sedative and sleep-inducing properties.
ROHYPNOL® is available as film-coated tablet containing 1 mg Flunitrazepam and indicated in short-term treatment of insomnia. It is subject to medicinal prescription (mostly via special narcotic prescription).


DORMICUM®, with its active ingredient midazolam, belongs to the pharmaceutical group of benzodiazepines representing a centrally depressant psychotropic drug that exerts anxiolytic, anticonvulsant, and muscle-relaxant effects. Midozolam is included in the WHO list of essential medicines in the section preoperative medication and sedation for short-term procedures. DORMICUM® is available as film-coated tablet as well as solution for injection containing midazolam in various strengths. It is indicated for short-term treatment of severe or disabling insomnia, sedation in premedication of anaesthesia and for diagnostic or surgical procedures as well as for sedation in intensive care units.