Kalnonon

カルノノノール塩酸塩(カルノノノール)眼科溶液1%は眼圧の低下に効果的であることが示されており、慢性開放隅角緑内障および眼内圧 ⁇ 進症の患者に使用できます。. 単独で使用することも、他の眼内圧低下薬と組み合わせて使用 することもできます。.

The usual dose is one drop of Kalnononol Hydrochloride (Kalnononol) Ophthalmic Solution 1% in the affected eye(s) twice a day. If the patient's IOP is not at a satisfactory level on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine or dipivefrin, and/or systemically administered carbonic anhydrase inhibitors, such as acetazolamide, can be instituted.

カルノノノールは、気管支 ⁇ 息または気管支 ⁇ 息の病歴、または重度の慢性閉塞性肺疾患のある人には禁 ⁇ です(参照)。 警告。);副鼻腔徐脈; 2度目と3度の房室ブロック。明白な心不全(参照。 警告。);心原性ショック;またはこの製品の任意のコンポーネントに対する過敏症。.

WARNINGS

Kalnononol has not been detected in plasma following ocular instillation. However, as with other topically applied ophthalmic preparations, Kalnononol may be absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure, have been reported with topical application of beta-adrenergic blocking agents (see CONTRAINDICATIONS).

Cardiac Failure

Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure.

In Patients Without a History of Cardiac Failure

Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure, Kalnononol Hydrochloride (Kalnononol) should be discontinued.

Non-Allergic Bronchospasm

In patients with non-allergic bronchospasm or with a history of non-allergic bronchospasm (e.g., chronic bronchitis, emphysema), Kalnononol Hydrochloride (Kalnononol) Ophthalmic Solution should be administered with caution since it may block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta2 receptors.

Major Surgery

The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to major surgery is controversial. Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor blocking agents have been subject to protracted severe hypotension during anesthesia. For these reasons, in patients undergoing elective surgery, gradual withdrawal of beta-adrenergic receptor blocking agents may be appropriate.

If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of such agonists as isoproterenol, dopamine, dobutamine or levarterenol (see OVERDOSE).

Diabetes Mellitus

Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia.

Thyrotoxicosis

Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents which might precipitate a thyroid storm.

PRECAUTIONS

General

Kalnononol Hydrochloride (Kalnononol) Ophthalmic Solution should be used with caution in patients with known hypersensitivity to other beta-adrenoceptor blocking agents. Use with caution in patients with known diminished pulmonary function. In patients with angle-closure glaucoma, the immediate objective of treatment is to reopen the angle. This requires constricting the pupil with a miotic. Kalnononol has little or no effect on the pupil. When Kalnononol is used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be used with a miotic and not alone.

Risk from Anaphylactic Reaction

While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated accidental, diagnostic or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

Muscle Weakness

Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis and generalized weakness).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Kalnononol hydrochloride (Kalnononol) did not produce carcinogenic effects at doses up to 40 mg/kg/day in two-year oral rat and mouse studies. Test of mutagenicity, including the Ames Test, recombinant (rec)-assay, in vivocytogenetics and dominant lethal assay demonstrated no evidence for mutagenic potential. Fertility of male and female rats and male and female mice was unaffected by administration of Kalnononol hydrochloride (Kalnononol) dosages up to 150 mg/kg/day.

Pregnancy

Teratogenic Effects

Pregnancy Category C

Kalnononol hydrochloride (Kalnononol) increased resorptions and decreased fetal weights in rabbits and rats at maternally toxic doses approximately 1052 and 5264 times the maximum recommended human oral dose (10 mg/70 kg/day), respectively. A dose-related increase in wavy ribs was noted in the developing rat fetus when pregnant females received daily doses of approximately 212 times the maximum recommended human oral dose. No such effects were noted in pregnant mice subjected to up to 1052 times the maximum recommended human oral dose. There are no adequate and well-controlled studies in pregnant women. Kalnononol Hydrochloride (Kalnononol) Ophthalmic Solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk, although in animal studies Kalnononol has been shown to be excreted in breast milk. Caution should be exercised when Kalnononol Hydrochloride (Kalnononol) Ophthalmic Solution is administered to nursing mothers.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

以下の副作用は、塩酸カルノノノール(カルノノノノール)眼科溶液を用いた臨床試験で報告されています。.

眼。

一過性の眼の刺激、 ⁇ 熱感、裂傷、結膜過熱および浮腫は、4人の患者のうち約1人で発生しました。. かすみ目や ⁇ り目、恐怖症、暗視の低下、眼 ⁇ 下 ⁇ 炎、角膜の異常な染色、角膜過敏症などの眼の症状や眼の徴候が時折発生しました。.

全身。

非選択的アドレナリン遮断薬の特徴であるように、カルノノノールは徐脈と血圧低下を引き起こす可能性があります(参照。 警告。)。. 以下の全身事象は、塩酸カルノノノール(カルノノノノール)眼科溶液の使用で時折報告されています:心不整脈、心臓の動 ⁇ 、呼吸困難、無力症、頭痛、めまい、不眠症、副鼻腔炎、および味覚異常。. 以下の追加の副作用が、眼科でのベータの使用で報告されています。₁ そしてベータ。₂ (非選択的)アドレナリン作動性受容体遮断薬:。

全体としての体。

頭痛。

心血管。

不整脈、失神、心ブロック、脳血管障害、脳虚血、うっ血性心不全、動 ⁇ (参照) 警告。).

消化器。

吐き気。

精神科。

うつ病。

皮膚。

限局性発疹および全身性発疹を含む過敏症。

呼吸器。

気管支 ⁇ (主に既存の気管支 ⁇ 症の患者)、呼吸不全(参照。 警告。)

内分 ⁇ 。

インスリン依存性糖尿病患者における低血糖のマスクされた症状(参照。 警告。)

特別感覚。

角膜炎、眼 ⁇ 下垂、屈折変化を含む視覚障害(場合によってはミオティック療法の中止による)、複視、眼 ⁇ 下垂の兆候と症状。. 非選択的アドレナリン受容体遮断薬の経口使用に関連する他の反応は、これらの薬剤の眼科使用による潜在的な影響と見なされるべきです。.

ヒトの過剰摂取の緊急治療に関する特定の情報はありません。. 偶発的な眼の過剰摂取が発生した場合は、目を水または通常の生理食塩水で洗い流してください。. ベータアドレナリン遮断薬の過剰摂取で予想される最も一般的な影響は、徐脈、気管支 ⁇ 、うっ血性心不全および低血圧です。.

摂取する場合は、塩酸カルノノノール(カルノノノノール)による治療を中止し、胃洗浄を検討する必要があります。. 患者は注意深く観察され、バイタルサインは注意深く監視されるべきです。. 矯正療法の期間を決定する際には、カルノノノールの長期間の影響を考慮する必要があります。. 薬理学的プロファイルに基づいて、以下の追加の対策を適切に検討する必要があります。

症候性副鼻腔徐脈または心臓ブロック。

アトロピンを投与します。. ⁇ 封鎖に対する反応がない場合は、イソプロテレノールを慎重に投与してください。.

気管支 ⁇ 。

ベータ版を管理します。₂-イソプロテレノールおよび/またはテオフィリン誘導体などの刺激剤。.

うっ血性心不全。

必要に応じて利尿薬とジギタリス配糖体を投与します。.

低血圧。

静脈内ドーパミン、エピネフリン、ノルエピネフリン酒石酸塩などの血管プレッサーを投与します。.