AU2257997A - Method of treatment and pharmaceutical composition - Google Patents
Method of treatment and pharmaceutical compositionInfo
- Publication number
- AU2257997A AU2257997A AU22579/97A AU2257997A AU2257997A AU 2257997 A AU2257997 A AU 2257997A AU 22579/97 A AU22579/97 A AU 22579/97A AU 2257997 A AU2257997 A AU 2257997A AU 2257997 A AU2257997 A AU 2257997A
- Authority
- AU
- Australia
- Prior art keywords
- phenyl
- loratadine
- sodium
- pharmaceutical formulation
- leukotriene antagonist
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/4045—Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/403—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil condensed with carbocyclic rings, e.g. carbazole
- A61K31/404—Indoles, e.g. pindolol
- A61K31/405—Indole-alkanecarboxylic acids; Derivatives thereof, e.g. tryptophan, indomethacin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4365—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system having sulfur as a ring hetero atom, e.g. ticlopidine
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/08—Antiallergic agents
Description
CROSS REFERENCE TO RELATED APPLICAΗON
This application is based on, and claims priority from, provisional application number 60/011,328 filed February 8, 1996.
TITLE OF THE INVENTION
METHOD OF TREATMENT AND PHARMACEUTICAL
COMPOSITION
BACKGROUND OF THE INVENTION
Loratadine is an antihistamine with H-receptor antagonist properties useful in the treatment of allergies and is described in U.S. Patent 4,282,233.
Leukotriene antagonists are known to be useful in the treatment of asthma, allergic reactions, and inflammation.
Now with the present invention, there is provided a method of treating asthma, allergy and inflammation with a combination of these two agents which is more efficacious than either agent by itself.
SUMMARY OF THE INVENTION
This invention is concerned with a method of treatment of asthma, allergy and inflammation by administration of an effective amount of loratadine and an effective amount of a leukotriene antagonist either by essentially concurrent administration or combined in a single pharmaceutical composition wherein the leukotriene antagonist is selected from:
A. Sodium 1 -(((R)-(3-(2-(7-chloro-2-quinolinyl)ethenyl)phenyl)-3-(2- (2-hydroxy-2-propyl)phenyl)thio)methyl)cyclopropaneacetate, EP 480,717
Montelukast Sodium
Sodium l-(((R)-(3-(2-(6,7-difluoro-2-quinolinyl)ethenyl)- phenyl)-3-(2-(2-hydroxy-2-propyl)phenyl)thio)methyl)cyclo- propaneacetate. U.S. 5,270,324
l-(((l(R)-(3-(2-(2,3-dichlorothieno[3,2-b]pyridin-5-yl)-(E)- ethenyl)phenyl)-3-(2-( 1 -hydroxy- 1 -methylethyl)phenyl)- propyl)thio)methyl)cyclopropaneacetic acid or sodium salt thereof. U.S. 5,472,964
N-[4-oxo-2-(lH-tetrazol-5-yl)-4H-l-benzopyran-8-yl]-p-(4- phenylbutoxy)benzamide. EP 173,516
Pranlukast
Cyclopentyl- 3- [2-methoxy-4- [(o-tol ylsulf ony l)carbamoyl] - benzyl]- l-methylindole-5-carbamate. EP 199,543
Zafirlukast
DETAILED DESCRIPTION OF THE INVENTION
The novel pharmaceutical composition of this invention comprises a combination of loratadine and a leukotriene antagonist selected from A, B, C, D and E, described above, as active ingredients, and optionally a pharmaeutically acceptable carrier suitable for enteral or parenteral administration. The formulations may be in solid form, as for example tablets and capsules, or in liquid form, as for example, syrups, elixirs, emulsions and injectables. In the formulation of pharmaceutical dosage forms there generally is utilized excipients such as water, gelatin, lactose starches, magnesium stearate, talc, vegetable oils, benzyl alcohol, gums, polyalkylene glycols, and petroleum jelly. A preferred formulation is mere fully described in the following Example.
In the novel method of treatment of this invention, the loratadine and leukotriene antagonist can be administered substantially concurrently as separate dosage forms or combined in the novel pharmaceutical formulation of this invention.
Although the required dosage will be determined by such factors as the patients age, sex, weight and severity of the condition being treated, the preferred human oral dosage range is about 5 to 20 mg., loratadine, 1 to 3 times per day; preferably about 10 mg. once a day. In the case of the leukotrienes, the human dosage range is also about 5 to 20 mg 1 to 3 times per day; preferably about 10 mg. once a day.
EXAMPLE
Montelukast Sodium 10 mg and Loratadine 10 mg Film Coated Tablet
Amt. Per Ingredient Tablet
Core
10.4 mg Montelukast Sodium
10.0 mg Loratadine
66.6 mg Microcrystalline Cellulose, NF
100.0 mg Lactose Monohydrate, NF
6.0 mg Croscarmellose Sodium, NF
(60.0 mg) Purified Water, USP
1.0 mg Magnesium Stearate, NF
200.0 mg Core Tablet
Film Coating
2.25 mg Hydroxypropyl Methylcellulose 6 cps
1.25 mg Hydroxypropyl Cellulose LF
1.50 mg Titanium Dioxide
(33.5) mg Purified Water
205.0 mg Film Coated Tablet
Claims (12)
1. A pharmaceutical formulation comprising as active ingredients loratadine and a leukotriene antagonist selected from (A) montelukast sodium;
(B) Sodium l-(((R)-(3-(2-(6,7-difluoro-2-quinolinyl) ethenyl)phenyl) -3-(2-(2-hydroxy-2-propyl)phenyl) thio)methylcyclopropaneacetate;
(C) l-(((l(R)-(3-(2-(2,3-dichlorothieno[3,2-b]pyridin-5-yl)-(E)- ethenyl)phenyl)-3-(2-( 1 -hydroxy- 1 -methylethyl)phenyl)propyl) thio)methyl)cyclopropaneacetic acid or a sodium salt thereof;
(D) pranlukast; and
(E) zafϊrlukast; and a pharmaceutically acceptable carrier.
2. The composition of Claim 1 which is designed for oral administration.
3. The composition of Claim 2 comprising 10 mg of loratadine and 10 mg of a leukotriene antagonist selected from (A),
(B), (C), (D) and (E).
4. The composition of Claim 1, wherein the leukotriene antagonist is montelukast sodium.
5. The composition of Claim 4 which is designed for oral administration.
6. The composition of Claim 5, comprising 10 mg of each active ingredient.
7. A method of treating asthma, allergy and inflammation in a patient in need of such treatment by the administration of an effective amount of loratadine and an effective amount of a leukotriene antagonist selected from:
(A) montelukast sodium;
(B) sodium l-(((R)-(3-(2-(6,7-difluror-2-quinolinyl)ethenyl)phenyl)-3- (2-(2-hydroxy-2-propyl)phenyl)thio)methyl)cyclopropaneactate;
(C) l-(((l(R)-(3-(2-(2,3-dichlorothieno[3,2-b]pyridin-5-yl)-(E)- ethenyl)phenyl)-3-(2-( 1 -hydroxy- 1 -methylethyl)- phenyl)propyl)thio)methyl)cyclopropaneacetic acid or a sodium salt thereof; (D) pranlukast; and (E) zafirlukast; either substantially concurrently in separate dosage forms or combined in the single pharmaceutical formulation of Claim 1.
8. The method of Claim 7, wherein the pharmaceutical formulation is designed for oral administration.
9. The method of Claim 7 wherein the separate dosage forms and the single pharmaceutical formulation comprise 10 mg of loratadine and 10 mg of a leukotriene antagonist selected from (A), (B), (C), (D) and (E).
10. The method of Claim 7 wherein the leukotriene antagonist is (A) montelukast sodium.
11. The method of Claim 10 wherein the separate dosage forms and single pharmaceutical formulation are designed for oral administration.
12. The method of Claim 11 wherein the separate dosage forms and the single pharmaceutical formulation comprise 10 mg of loratadine and 10 mg of (A), montelukast sodium.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US1132896P | 1996-02-08 | 1996-02-08 | |
US60/011328 | 1996-02-08 | ||
GB9608927 | 1996-04-29 | ||
GBGB9608927.1A GB9608927D0 (en) | 1996-04-29 | 1996-04-29 | Method of treatment and pharmaceutical composition |
PCT/US1997/001799 WO1997028797A1 (en) | 1996-02-08 | 1997-02-04 | Method of treatment and pharmaceutical composion |
Publications (2)
Publication Number | Publication Date |
---|---|
AU2257997A true AU2257997A (en) | 1997-08-28 |
AU732671B2 AU732671B2 (en) | 2001-04-26 |
Family
ID=26309231
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
AU22579/97A Ceased AU732671B2 (en) | 1996-02-08 | 1997-02-04 | Method of treatment and pharmaceutical composition |
Country Status (19)
Country | Link |
---|---|
EP (1) | EP1014972A4 (en) |
JP (1) | JPH11504044A (en) |
KR (1) | KR19990082367A (en) |
CN (1) | CN1210465A (en) |
AU (1) | AU732671B2 (en) |
BG (1) | BG102669A (en) |
BR (1) | BR9707369A (en) |
CA (1) | CA2245162A1 (en) |
CZ (1) | CZ248798A3 (en) |
EE (1) | EE9800234A (en) |
IL (1) | IL125446A0 (en) |
IS (1) | IS4805A (en) |
NO (1) | NO983641L (en) |
NZ (1) | NZ331160A (en) |
PL (1) | PL328074A1 (en) |
SK (1) | SK105698A3 (en) |
TR (1) | TR199801511T2 (en) |
WO (1) | WO1997028797A1 (en) |
YU (1) | YU33298A (en) |
Families Citing this family (22)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7214683B1 (en) | 1994-12-30 | 2007-05-08 | Sepracor Inc. | Compositions of descarboethoxyloratadine |
US7211582B1 (en) | 1994-12-30 | 2007-05-01 | Sepracor Inc. | Methods for treating urticaria using descarboethoxyloratadine |
GB9723985D0 (en) | 1997-11-14 | 1998-01-14 | Zeneca Ltd | Pharmaceutical compositions |
SK286103B6 (en) * | 1997-12-23 | 2008-03-05 | Schering Corporation | Pharmaceutical composition for treating respiratory and skin diseases, comprising at least on leucotriene antagonist and at least one antihistamine, and the use of the same |
US6194431B1 (en) | 1998-04-14 | 2001-02-27 | Paul D. Rubin | Methods and compositions using terfenadine metabolites in combination with leukotriene inhibitors |
US6384038B1 (en) * | 1998-04-14 | 2002-05-07 | Sepracor Inc. | Methods and compositions using cetirizine in combination with leukotriene inhibitors or decongestants |
US6248308B1 (en) | 1998-04-14 | 2001-06-19 | Sepracor Inc. | Methods of using norastemizole in combination with leukotriene inhibitors to treat or prevent asthma |
US6262066B1 (en) | 1998-07-27 | 2001-07-17 | Schering Corporation | High affinity ligands for nociceptin receptor ORL-1 |
ID29137A (en) * | 1998-07-27 | 2001-08-02 | Schering Corp | HIGH AFINITY LIGANS FOR ORL-1 NOSISEPTIN RECEPTORS |
CO5271713A1 (en) * | 1998-09-10 | 2003-04-30 | Schering Corp | METHODS AND COMPOSITIONS TO TREAT SINUSITIS, MEDIUM OTITIS AND OTHER RELATED DISORDERS USING ANTIHISTAMINS |
WO2000057880A1 (en) * | 1999-03-29 | 2000-10-05 | Schering Corporation | Methods and compositions for treating allergic and related disorders using fluorinated descarboethoxyloratadine |
DE10007203A1 (en) * | 2000-02-17 | 2001-08-23 | Asta Medica Ag | Composition for treating allergic and/or vasomotor rhinitis or allergic conjunctivitis by topical or oral administration, contains synergistic combination of non-sedating antihistamine and leukotriene antagonist |
WO2002036124A2 (en) * | 2000-10-30 | 2002-05-10 | Schering Corporation | Treatment and method using loratadine and montelukast |
US20020198228A1 (en) * | 2001-04-03 | 2002-12-26 | Kaura Sita R. | Composition and method for the treatment of respiratory desease |
WO2004087095A2 (en) * | 2003-03-31 | 2004-10-14 | Osmotica Costa Rica, Sociedad Anonima | Osmotic controlled release device containing zafirlukast and an h1-antagonist |
WO2005037245A2 (en) * | 2003-10-21 | 2005-04-28 | Direct-Haler A/S | A multiple route medication for the treatment of rhinitis and asthma |
WO2005089748A1 (en) * | 2004-03-17 | 2005-09-29 | Pfizer Limited | Combination for treating inflammatory diseases |
EP1817034A1 (en) | 2004-10-25 | 2007-08-15 | Schering Corporation | M1 and/or m3 receptor antagonists in combination with other actives for treating respiratory disorders |
TR200806298A2 (en) * | 2008-08-22 | 2010-03-22 | Bi̇lgi̇ç Mahmut | Pharmaceutical formulation |
TW201111392A (en) | 2009-06-16 | 2011-04-01 | Schering Corp | Novel [3,2-c] heteroaryl steroids as glucocorticoid receptor agonists, compositions and uses thereof |
KR101540191B1 (en) * | 2014-02-24 | 2015-07-28 | 성균관대학교산학협력단 | Composition comprising Loratadine for anti-inflammation |
EP3908284A4 (en) * | 2019-01-10 | 2023-02-08 | EnliTISA (Shanghai) Pharmaceutical Co., Ltd. | New formulations containing leukotriene receptor antagonists |
Family Cites Families (7)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4282233B1 (en) * | 1980-06-19 | 2000-09-05 | Schering Corp | Antihistaminic 11-(4-piperidylidene)-5h-benzoÄ5,6Ü-cyclohepta-Ä1,2Ü-pyridines |
CA1261835A (en) * | 1984-08-20 | 1989-09-26 | Masaaki Toda | (fused) benz(thio)amides |
GB8607294D0 (en) * | 1985-04-17 | 1986-04-30 | Ici America Inc | Heterocyclic amide derivatives |
US5565473A (en) * | 1990-10-12 | 1996-10-15 | Merck Frosst Canada, Inc. | Unsaturated hydroxyalkylquinoline acids as leukotriene antagonists |
US5270324A (en) * | 1992-04-10 | 1993-12-14 | Merck Frosst Canada, Inc. | Fluorinated hydroxyalkylquinoline acids as leukotriene antagonists |
US5472964A (en) * | 1992-12-22 | 1995-12-05 | Merck Frosst Canada, Inc. | Diaryl 5,6-fused heterocyclic acids as leukotriene antagonists |
US5595997A (en) * | 1994-12-30 | 1997-01-21 | Sepracor Inc. | Methods and compositions for treating allergic rhinitis and other disorders using descarboethoxyloratadine |
-
1997
- 1997-02-04 CZ CZ982487A patent/CZ248798A3/en unknown
- 1997-02-04 SK SK1056-98A patent/SK105698A3/en unknown
- 1997-02-04 PL PL97328074A patent/PL328074A1/en unknown
- 1997-02-04 TR TR1998/01511T patent/TR199801511T2/en unknown
- 1997-02-04 EP EP97905757A patent/EP1014972A4/en not_active Withdrawn
- 1997-02-04 KR KR1019980706097A patent/KR19990082367A/en not_active Application Discontinuation
- 1997-02-04 AU AU22579/97A patent/AU732671B2/en not_active Ceased
- 1997-02-04 EE EE9800234A patent/EE9800234A/en unknown
- 1997-02-04 CN CN97192149A patent/CN1210465A/en active Pending
- 1997-02-04 JP JP9528627A patent/JPH11504044A/en active Pending
- 1997-02-04 CA CA002245162A patent/CA2245162A1/en not_active Abandoned
- 1997-02-04 IL IL12544697A patent/IL125446A0/en unknown
- 1997-02-04 WO PCT/US1997/001799 patent/WO1997028797A1/en not_active Application Discontinuation
- 1997-02-04 NZ NZ331160A patent/NZ331160A/en unknown
- 1997-02-04 BR BR9707369A patent/BR9707369A/en not_active Application Discontinuation
-
1998
- 1998-07-22 IS IS4805A patent/IS4805A/en unknown
- 1998-08-05 BG BG102669A patent/BG102669A/en unknown
- 1998-08-06 YU YU33298A patent/YU33298A/en unknown
- 1998-08-07 NO NO983641A patent/NO983641L/en unknown
Also Published As
Publication number | Publication date |
---|---|
PL328074A1 (en) | 1999-01-04 |
TR199801511T2 (en) | 1998-10-21 |
KR19990082367A (en) | 1999-11-25 |
SK105698A3 (en) | 1999-05-07 |
EE9800234A (en) | 1998-12-15 |
JPH11504044A (en) | 1999-04-06 |
AU732671B2 (en) | 2001-04-26 |
YU33298A (en) | 1999-11-22 |
WO1997028797A1 (en) | 1997-08-14 |
EP1014972A1 (en) | 2000-07-05 |
CN1210465A (en) | 1999-03-10 |
NO983641D0 (en) | 1998-08-07 |
IS4805A (en) | 1998-07-22 |
CA2245162A1 (en) | 1997-08-14 |
NO983641L (en) | 1998-08-07 |
BG102669A (en) | 1999-04-30 |
EP1014972A4 (en) | 2004-12-08 |
CZ248798A3 (en) | 1999-01-13 |
IL125446A0 (en) | 1999-03-12 |
NZ331160A (en) | 2000-07-28 |
BR9707369A (en) | 1999-07-20 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
FGA | Letters patent sealed or granted (standard patent) | ||
MK14 | Patent ceased section 143(a) (annual fees not paid) or expired |