Zack Pharma

One limitation of sulfonylurea therapy is the inability to stimulate insulin release from beta cells at extremely high glucose levels, which is called glucose toxicity.

February 21, 2020
FDA Approved newer antilipemic agent.

Bempedoic Acid

Mechanism of Action
Bempedoic acid is an adenosine triphosphate-citrate lyase (ACL) inhibitor that lowers low-density lipoprotein cholesterol (LDL-C) by inhibiting cholesterol synthesis in the liver.

Bempedoic acid and its active metabolite ESP15228 require coenzyme A (CoA) and activation by very long-chain acyl-CoA synthetase 1 (ACSVL1) to Bempedoyl-CoA and ESP15228-CoA.

ACSVL1 is expressed primarily in the liver.
Inhibition of ACL by Bempedoyl-CoA results in decreased cholesterol synthesis in the liver and lowers LDL-C in blood via upregulation of LDL receptors.

Adverse Reactions (Significant):
Hyperuricemia
Tendon rupture

Dosing:
180 mg once daily.

Pregnancy Considerations:
In utero exposure to bempedoic acid may cause fetal harm.

Breastfeeding Considerations:
Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer.

Monitoring Parameters:
Monitor lipid levels within 8 to 12 weeks of therapy initiation. Signs/symptoms of hyperuricemia.
Signs/symptoms of tendinopathy or tendon rupture (eg, joint pain, swelling, inflammation).

Under conditions of perfect adherence,
the pregnancy rate in womens who take combination contraceptive would be 0.5–1 per 100 woman-years.

من الأسباب التي تؤدي الي حدوث الحمل مع
combination contraceptive

1-When one or more doses are missed.
2-Womens who taken phenytoin (increase catabolism of the compounds).
3-If antibiotics are taken that alter enterohepatic cycling of metabolites. And
that's because:
Estrogen Pharmacokinetics
Metabolism:
significant amounts of estrogen are conjugated in the liver, then excreted in the bile and reabsorbed from the intestine after deconjugation by bacterial flora.

so taking antibiotics that killing normal flora may affect estrogen effect.

The only FDA drug approval for
benign prostatic hyperplasia from PDE-5
is "Tadalafil".

So in patients with concomitant erectile dysfunction, may use as initial monotherapy, in patients without ED, may use as an alternative to initial monotherapy with an alpha-1 blocker (eg, tamsulosin).

Cialis: Oral: 5 mg once daily

Exact mechanism unknown; effects likely due to PDE-5 mediated reduction in smooth muscle and endothelial cell proliferation, decreased nerve activity, and increased smooth muscle relaxation and tissue perfusion of the prostate and bladder.

Alzheimer disease new FDA drug approval.
January 06, 2023

Lecanemab

*Only for patients who are apolipoprotein E ε4 (ApoE ε4) homozygotes (approximately 15% of Alzheimer disease patients).

Pharmacologic Category
Anti-Amyloid Monoclonal Antibody

Mechanism of Action
Lecanemab is a humanized monoclonal antibody directed against aggregated soluble and insoluble forms of amyloid beta. Lecanemab reduces amyloid beta plaques.

Dosing:
​Alzheimer disease: IV: Dosing based on actual body weight: 10 mg/kg once every 2 weeks.

Storage/Stability
Store intact vial at 2°C to 8°C. Store in the original carton to protect from light. If not administered immediately, may store diluted solution at 2°C to 8°C or at room temperature up to 30°C for up to 4 hours.

ALERT: US Boxed Warning
can cause amyloid-related imaging abnormalities (ARIA), characterized as ARIA with edema (ARIA-E). Incidence and timing of ARIA vary among treatments. ARIA usually occurs early in treatment and is usually asymptomatic, although serious and life-threatening events rarely can occur.

*Monitoring Parameters
.lumbar puncture to confirm presence of amyloid beta pathology Brain MRI (prior to initiation [within 1 year].prior to 5th, 7th, 14th infusions; periodically as appropriate in the setting of amyloid-related imaging abnormalities (ARIA).

Drug cost;
$26,500 a year

Hiccups
Involuntary contractions of the diaphragm, the muscle that separates the chest from the abdomen. They are usually harmless and go away on their own within a few minutes. sometimes hiccups can be persistent or even chronic, lasting for days or weeks.

●A "hiccup bout" is an episode of hiccups lasting up to 48 hours

●"Persistent hiccups" are hiccups that continue longer than 48 hours and up to one month

●"Intractable hiccups" are hiccups that continue longer than one month

Cause;
There are many different causes of hiccups, including:

* Eating or drinking too quickly
* Certain medications (Dexamethasone)
* Central nervous system disorders (encephalitis and meningitis)
*Vagus and phrenic nerve irritation
*Gastrointestinal disorders (gastroesophageal reflux)
*Cardiac disorders (myocardial infarction)

Bouts of hiccups are common and usually do not require medical evaluation.
Persistent and intractable hiccups may necessitate a thorough medical evaluation.

Treatment should be directed toward the specific illness causing the hiccups, if known.
If no cause can be identified,
can start with physical maneuvers like
-Breath holding -Ice water gargles
-Swallowing granulated sugar -Noxious odors
-Valsalva maneuver -Fright

If physical maneuvers fail,
can use pharmacologic treatment

start with Chlorpromazine
Oral: Initial: 25 mg 3 to 4 times daily; may increase to 50 mg 3 to 4 times daily if needed and tolerated; maximum dose: 200 mg/day. In patients who may be sensitive to adverse effects (hypotension, sedation) lower initial dose of 10 mg 3 times daily.

The only FDA drug approval for Hypotrichosis of the eyelashes
is,
Bimatoprost

*Structural analog of prostaglandin F2α (PGF2α).

*How to use,
Place one drop on applicator and apply evenly along the skin of the upper eyelid at base of eyelashes once daily at bedtime; repeat procedure for second eye (use a clean applicator).

New FDA Drug Approval.
August 05, 2023

Avacincaptad Pegol

Pharmacologic Category
Complement C5 Inhibitor; Complement Inhibitor; Ophthalmic Agent

Use:
Geographic atrophy: Treatment of geographic atrophy secondary to age-related macular degeneration.

Contraindications
Ocular or periocular infections; active intraocular inflammation.

New FDA Drug Approval.
August 4, 2023

zuranolone

*Pharmacological category:
Anti-Depressant drug

*uses:
Postpartum depression.
The First FDA-Approved Oral Pill For Postpartum Depression

*Mechanism of action:
thought to work via positive allosteric modulation of GABA-A receptors. The GABA system is the major inhibitory signaling pathway of the brain and central nervous system and contributes to regulating brain function. Altered neurotransmission of GABA has been implicated in the pathogenesis of depression.

*Administration:
pills are administered orally once daily in the evening with fat-containing food, for 14 days.

** Here are informations about Postpartum depression.
A serious and potentially life-threatening condition in which women experience sadness, guilt, worthlessness—even, in severe cases, thoughts of harming themselves or their child. And, because postpartum depression can disrupt the maternal-infant bond, it can also have consequences for the child’s physical and emotional development.

Monoclonal antibody used in:
Homozygous familial hypercholesterolemia (type 2) "E78.01"

Evolocumab
*Mechanism of Action
Evolocumab is a human monoclonal antibody (IgG2 isotype) that binds to proprotein convertase subtilisin kexin type 9 (PCSK9). PCSK9 binds to the low-density lipoprotein receptors (LDLR) on hepatocyte surfaces to promote LDLR degradation within the liver. LDLR is the primary receptor that clears circulating LDL; therefore, the decrease in LDLR levels by PCSK9 results in higher blood levels of LDL-cholesterol (LDL-C). By inhibiting the binding of PCSK9 to LDLR, evolocumab increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.

*Dosing:
SUBQ: Initial: 420 mg once monthly; may increase to 420 mg once every 2 weeks if clinically meaningful response is not achieved in 12 weeks.

*Drug Interactions
Efgartigimod Alfa: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy.
Rozanolixizumab: May diminish the therapeutic effect of Fc Receptor-Binding Agents. Risk C: Monitor therapy.

*Storage/Stability
Store between 2°C to 8°C (36°F to 46°F) in the original carton. May also store at room temperature (at 20°C to 25°C [68°F to 77°F]) in the original carton; however, under these conditions, must use within 30 days (discard if not used within 30 days). Protect from direct light and do not expose to temperatures above 25°C (77°F). Do not freeze.

New FDA Drug Approval.
July 17, 2023.

(Nirsevimab)

Pharmacologic Category
Immune Globulin (Monoclonal Antibody).

Mechanism of Action
Nirsevimab, a respiratory syncytial virus F protein-directed fusion inhibitor, is a human immunoglobulin G1 (IgG1) kappa monoclonal antibody with antirespiratory syncytial virus activity.

Use: Labeled Indications
Respiratory syncytial virus, prophylaxis: Prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in neonates and infants born during or entering their first RSV season and pediatric patients up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.

Product Availability
Beyfortus

Metronidazole and Ciprofloxacin, Drug-Drug interaction.

Risk Rating C: Monitor therapy.
Patient Management:
Agents should be performed with caution; close monitoring for evidence of excessive QT prolongation or torsades de pointes (TdP) may be advisable. Such concomitant use may substantially increase the risk for serious toxicities, including the development of TdP or other significant ventricular tachyarrhythmias. Patients with other risk factors present (e.g., older age, female s*x, bradycardia, hypokalemia, hypomagnesemia, heart disease, and higher drug concentrations), would be at an even higher risk for these potentially life-threatening toxicities.

New FDA Drug Approval.
July 25, 2023
(Lotilaner)

Pharmacologic Category
Antiparasitic Agent, Ophthalmic

Use:
Demodex blepharitis: Treatment of Demodex blepharitis.

Product Availability
Xdemvy